Qualigen Fastpack.
is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. During the FastPack IP and FastPack® production process, Qualigen generates a master standard curve and places this information in the barcode of each FastPack® IP and FastPack® label, where it can be read by the FastPack® IP Analyzer during the testing sequence. This novel, rapid and highly accurate immunoassay testing system consists of the FastPack Analyzer and the FastPack test pouch: a single-use, disposable, foil packet which includes the FastPack reagent chemistry. Sekisui Diagnostics to market Qualigen's FastPack IP System: Lexington, Massachusetts Thursday, August 4, 2016, 13:00 Hrs [IST] Sekisui Diagnostics has significantly expanded its point of care (POC) diagnostics product line through a recent partnership agreement with Qualigen, Inc. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. Our products include fastpack® IP system, TSH, Free T4, hcG, Total PSA, and Testo. , formerly Ritter Pharmaceuticals, Inc. The sale of this item may be subject to regulation by the U. The FastPack® IP Testosterone Immunoassay is designed for use with the FastPack® IP System. Class 2 Device Recall Qualigen FastPack IP Vitamin D Immunoassay Kit Complete. Qualigen Therapeutics, Inc. Hackers, corporate IT professionals, and three letter government agencies all converge on Las Vegas every summer to absorb cutting edge hacking research from the most brilliant minds in the world and test their skills in contests of hacking might. related to the initiation of technology transfer of the FastPack system. Qualigen Therapeutics Submits Notification to FDA to Commence Distribution of its FastPack® COVID-19 Antibody Test. Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack® Diagnostics Products in China PR Newswire - PRF - Tue Jan 26, 8:02AM CST CMTX - Tue Jan 26, 8:02AM CST. Analysts are initiating coverage of Qualigen Therapeutics (QLGN) with a valuation price tag of $10. 4%) has begun commercial shipments of its FastPack SARS-CoV-2 IgG diagnostic test for COVID-19 antibodies. , as well as of other Qualigen trade secrets, (ii) delivering (at Sekisui’s expense) all physical FastPack 2. - 3/1/2021 8:30:00 AM Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack® Diag. Qualigen has been producing high-quality diagnostic testing products for almost 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people's lives. Qualigen's FastPack IP SHBG Immunoassay receives US FDA approval: Carlsbad, California Thursday, January 31, 2019, 16:00 Hrs [IST] Qualigen, Inc, a privately-owned company that provides novel diagnostic and therapeutic technologies for the treatment of cancer and infectious diseases, has received clearance from the US Food and Drug Administration for its FastPack IP Sex Hormone Binding. Qualigen is a biotechnology company focused on the development and commercialization of novel therapeutic products for the treatment of cancer and infectious diseases, as well as expansion of its flagship FastPack® diagnostic platform. FastPack®) TSH Controls Qualigen, Inc. Sekisui Diagnostics, Qualigen partnership, 10/16. #25000043 / FastPack® IP Free T4 Kit (30) #25000040 / FastPack® IP Total PSA Kit (30) #25000041 / FastPack® IP Testo Kit (30) #25000068 / FastPack® IP Vitamin D Kit Complete. Qualigen’s FastPack® test uses a particular antigen, which is also used in their COVID-19 antibody tests by major testing companies including Abbott Laboratories, Roche Diagnostics and Bio-Rad Laboratories. , a privately-owned company focused on the development and commercialization of novel therapeutic products for the treatment of cancer and infectious diseases, as well as expansion of its flagship FastPack® diagnostic platform, announced today the issuance of U. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for 20 years. Used QUALIGEN Fastpack Blood Analyzer For Sale - DOTmed Listing #1885867: QUALIGEN FastPack IP System- Quantitative Immunoassay Analyzer. ("Yi Xin"), of Suzhou, China, for Yi Xin to develop, manufacture and sell new generations of diagnostic test systems based on our core FastPack technology. Qualigen products. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein inhibitor that. The Company’s cancer. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today it has entered into a Material Evaluation and Option Agreement with the University College London (UCL) to advance development of and potentially expand toward future. The FastPack® IP System Control Kit is an assayed control for verification of the accuracy and precision of the FastPack® IP System when used for the quantitative determination of TSH, Free T4, Total PSA, Testosterone and hCG analytes. May-18-21 02:10PM : Qualigen Therapeutics Inc to Host Earnings Call. Qualigen, Inc. In January 2021, Qualigen announced the achievement of a milestone event that triggered a payment obligation from Yi Xin Duan Jishu (Suzhou) Ltd. Qualigen Therapeutics, Inc. Qualigen Therapeutics Inc, a biotechnology company, announced agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd, of Suzhou, China to develop, manufacture and sell new generations of diagnostic test systems based on Qualigen's core FastPack "laboratory in a pouch" technology. The Company is focused on the development and commercialization of therapeutic products for the. [NASDAQ: QLGN] jumped around 0. Ref: 08000036. Timely, accurate immunoassay testing for physician offices. Qualigen Therapeutics Submits Notification to FDA to Commence Distribution of its FastPack® COVID-19 Antibody Test. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Carlsbad-based diagnostic test maker Qualigen Inc. Qualigen Therapeutics Revenue (TTM): 4. Sekisui owns approximately 15. Qualigen on LinkedIn, Twitter & YouTube. Qualigen Therapeutics, Inc. GlobeNewswire. Qualigen Therapeutics Inc (NASDAQ: QLGN) shares are ticking lower as the company withdrew the FDA Emergency Use Authorization (EUA) application for its FastPack SARS-CoV-2 IgG diagnostic test for. Analysts are initiating coverage of Qualigen Therapeutics (QLGN) with a valuation price tag of $10. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. Manufacturer: Qualigen, Inc. Qualigen Therapeutics | 471 followers on LinkedIn. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated g. Upper Limit of 1600 ng/dL. Qualigen fastpack. FastPack IP Free PSA chemiluminescent immunoassay is for the in-vitro quantitative determination of free prostate-specific antigen (free PSA) in human serum. Sistema FastPack® IP – Qualigen. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic point-of-care system. The FastPack® System is a proprietary diagnostics platform launched by Qualigen in 2001. It had developed the Fastpack Testo Immunoassay. (QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today that according to a preliminary list of additions posted June 4 it will be added to the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective on June 28, 2021. Since receiving an elevated PSA test result using a FastPack immunoassay test at a 2008 Hall of Fame event sponsored by Qualigen and the American Urological Association, Mr. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. About Qualigen Therapeutics, Inc. This novel, rapid and highly accurate immunoassay testing system consists of the FastPack Analyzer and the FastPack test pouch: a single-use, disposable, foil packet which includes the FastPack reagent chemistry. Each FastPack® IP Testo Reagent Pack contains: Paramagnetic Particles - 150 µL, Testosterone. qualigen therapeutics inc - co believes there is no longer a viable business case for scale-up of test. , is a biotechnology company. 218135191. FastPack IP Vitamin D Immunoassay by Qualigen. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein inhibitor that. CARLSBAD, Calif. Qualigen Therapeutics, Inc. "This is an important step in the evolution of SARS-CoV-2 antibody testing, given the high number of inaccurate tests in the marketplace," said Michael Poirier, President, Chief Executive Officer and Chairman of. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. , formerly Ritter Pharmaceuticals, Inc. Qualigen, Inc. com) is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, using similar core nanoparticle coating technology from its FDA-approved FastPack ® System, which has been used successfully in diagnostics for over 15 years. , July 1, 2020 /PRNewswire/ -- Qualigen Therapeutics, Inc. Serial Number: 75399007. In addition, Yi Xin will have the rights to manufacture and sell Qualigen's. Haynes has been a. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic system - in essence, a "lab in a box" that allows test results to be delivered with the accuracy of large laboratories but much more rapidly. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack (R) System, which has been used successfully in diagnostics for 20 years. Our Approach Qualigen is a biotechnology company focused on the development and commercialization of therapeutic products for the treatment of cancer and viral diseases, as well as expansion of its flagship FastPack® diagnostic platform. Under the terms of an agreement announced in October 2020, Yi Xin will develop, manufacture and sell new generations of diagnostic test systems based on Qualigen's core FastPack® "laboratory in a pouch" technology, which includes high throughput diagnostic systems. Qualigen has been producing high-quality diagnostic testing products for almost 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people's lives. The Company’s cancer therapeutics pipeline. Lexington, MA August 2, 2016: Sekisui Diagnostics has significantly expanded its point of care (POC) diagnostics product line through a recent partnership agreement with Qualigen, Inc. The new test is designed for use with Qualigen's new FastPack ® PRO System point-of-care diagnostic instruments. Qualigen is a medical device company. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Further, it expects to launch marketing for FastPack PRO SARS-CoV-2 IgG antibodies test in the current quarter, which could see "rapid uptake," contends Molloy. Sekisui owns approximately 15. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. More About Us. , a privately-owned company focused on the development and commercialization of novel therapeutic products for the treatment of cancer and infectious diseases, as well. Check out our extensive catalog of New & Used Qualigen FastPack Immunoassay Analyzer, Enzyme devices. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for 20 years. It is estimated that thousands of lives have been saved by Qualigen's diagnostics. The FastPack® PRO System is an upgraded version of Qualigen's flagship FastPack® IP rapid immunoassay diagnostic point-of-care system. Qualigen Therapeutics, Inc. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. Carlsbad-based diagnostic test maker Qualigen Inc. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. Qualigen granted Yi Xin exclusive rights for China - a new market for Qualigen - both for Yi Xin's new generations of FastPack-based products and for Yi Xin-manufactured versions of Qualigen's. Qualigen fastpack. , warrants to. Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack® Diagnostics Products in China PR Newswire - PRF - Tue Jan 26, 8:02AM CST CMTX - Tue Jan 26, 8:02AM CST. Qualigen is a biopharmaceutical company developing novel treatments for cancer and infectious diseases while continuing and expanding its FDA approved FastPack® System. Carlsbad, California K052301 Device Description FastPack® Control Kit is prepared in a synthetic matrix containing chemicals, preservatives, and stabilizers with added analyte constituents of human and synthesized origin. , formerly Ritter Pharmaceuticals, Inc. In January 2021, Qualigen announced the achievement of a milestone event that triggered a payment obligation from Yi Xin Duan Jishu (Suzhou) Ltd. Quantitative Measurement of total testosterone. Qualigen Therapeutics, Inc. The FDA granted 510(k) clearance to Qualigen's FastPack IP sex hormone binding globulin (SHBG) immunoassay. Qualigen fastpack. The customers were instructed to stop using the products immediately; discard. The FastPack® PRO System is an upgraded version of Qualigen's flagship FastPack® IP rapid immunoassay diagnostic point-of-care system. Sekisui Diagnostics has assumed commercial activities and distribution management for the FastPack IP System and associated products in U. The FastPack® IP and FastPack® Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. FastPack® Testo Calibrator For use in conjunction with the FastPack® IP and Fastpack® Testo Immunoassay and ® the FastPack IP System Analyzer CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by or on the order of a physician. Qualigen's SARS-CoV-2 IgG immunoassay, for use with its new FastPack PRO System point-of-care diagnostic instruments, is a chemiluminescent microparticle test intended for the qualitative. Qualigen is currently continuing to identify a lead drug candidate with IND-enabling studies expected to complete in the second half of 2021 and an IND expected to be filed in the first half of 2022. The Qualigen FastPack ® IP system is the only available quantitative immunoassay analyzer featuring one-touch operation in delivering values for Thyroid Stimulating Hormone (TSH), Free. Its pipeline includes AS1411, Aptamer Linked Anti Nucleolin (ALAN), Aptamer Linked Anti Nucleolin. Manufacturer: Qualigen, Inc. , formerly Ritter Pharmaceuticals, Inc. On July 1, 2020, the company updated its submission of a notification to the FDA for the commencement of sales of FastPack® SARS-CoV-2 IgG test for C. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. (“Qualigen” or the “Company”), closed its Securities Purchase Agreement (dated December 16, 2020) with a single institutional investor for the purchase and sale for $12,000,000 of (i) 2,370,786 shares of Qualigen common stock, (ii) 1,000,000 pre-funded warrants (i. Sekisui Diagnostics is now the exclusive worldwide distributor of the FastPack IP System, Qualigen’s innovative. Qualigen, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. Qualigen Therapeutics Releases FastPack® SARS-CoV-2 Antibody Diagnostic Test to University of Louisville to Conduct Validation Studies Nome del media/mezzo di comunicazione TickerTech. Qualigen Therapeutics, Inc. Customer ID. Designed for use in conjunction with the FastPack IP System for calculating the ratio of free/total PSA, expressed as a percentage (percent free PSA) The. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including its flagship FastPack ® point-of-care immunoassay system and novel therapeutic technologies for treatment of cancers and infectious diseases. The FastPack® IP Testosterone Immunoassay is designed for use with the FastPack® IP System. (QLGN) Qualigen on Wikipedia, Google News & Yahoo Finance. About Qualigen Therapeutics, Inc. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. Qualigen has been producing high-quality diagnostic testing products for almost 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people's lives. On December 18, 2020, Qualigen Therapeutics, Inc. Thursday, 07/02/20 09:00:28 AM. Qualigen Therapeutics, Inc. It had developed the Fastpack Testo Immunoassay. Qualigen is a medical device company. 2042 CORTE DEL NOGAL SUITE B Carlsbad, CA 92011 -1438 : Contact: Michael S Poirier: Correspondent: Michael S Poirier Qualigen, Inc. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. For more information on. Qualigen FastPack Immunoassay Analyzer, Enzyme for Sale. Unlike tests at reference laboratories, the FastPack tests are conducted in physician. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Under the terms of an agreement announced in October 2020, Yi Xin will develop, manufacture. "This is an important step in the evolution of SARS-CoV-2 antibody testing, given the high number of inaccurate tests in the marketplace," said Michael Poirier, President, Chief Executive Officer and Chairman of. FastPack IP Free PSA chemiluminescent immunoassay is for the in-vitro quantitative determination of free prostate-specific antigen (free PSA) in human serum. The FastPack® PRO System is an upgraded version of Qualigen's flagship FastPack® IP rapid immunoassay diagnostic point-of-care system. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including novel therapeutic technologies for treatment of cancers and infectious diseases, as well as its flagship FastPack® point-of-care immunoassay system. The Company's cancer. Qualigen, Inc. , formerly Ritter Pharmaceuticals, Inc. CPT Code: 84403. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. Our therapeutics pipeline includes cancer drug. Qualigen Therapeutics, Inc. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. The Qualigen FastPack ® IP system is the only available quantitative immunoassay analyzer featuring one-touch operation in delivering values for Thyroid Stimulating Hormone (TSH), Free Thyroxine (fT4), Human Chorionic Gonadotropin (hCG), Prostate Specific Antigen (PSA) free PSA and Testosterone. Select Currency: USD EURO GBP US Dollars. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. Proporciona Inmunoensayos de alta precisión con calidad de laboratorio a través de un diseño ideal para el consultorio del médico o laboratorios pequeños. (“Qualigen” or the “Company”), closed its Securities Purchase Agreement (dated December 16, 2020) with a single institutional investor for the purchase and sale for $12,000,000 of (i) 2,370,786 shares of Qualigen common stock, (ii) 1,000,000 pre-funded warrants (i. Driven to Deliver | Qualigen is a biotechnology company focused on the development and commercialization of novel therapeutic products for the. Qualigen is a biotechnology company focused on the development and commercialization of novel therapeutic products for the treatment of cancer and infectious diseases, as well as expansion of its flagship FastPack® diagnostic platform. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Select Qualigen Manual you need on this page. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for almost 20 years. All products are sold “as is”, “where is”, “untested”, unless otherwise stated. Appoints Tariq Arshad, MD, MBA as Chief Medical Officer GlobeNewswire Inc. In reaction, the. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. Qualigen Therapeutics, Inc. FastPack¿ Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. , formerly Ritter Pharmaceuticals, Inc. Qualigen, Inc. com - August 16 at 6:14 PM. The FastPack System is an immunoassay testing system, which consists of the FastPack Analyzer and the FastPack test pouch, a single-use, disposable, foil packet which includes the FastPack reagent chemistry. Unlike tests at reference laboratories, the FastPack tests are conducted in physician. Its current commercial product is the FastPack rapid diagnostic testing system. Its pipeline includes AS1411, Aptamer Linked Anti Nucleolin (ALAN), Aptamer Linked Anti Nucleolin. The FastPack Vitamin D Controls are assayed quality control materials for the verification of the accuracy and precision of the FastPack IP System when used for the quantitative determination of Vitamin D in human serum and plasmaThe FastPack Vitamin D Calibrator is intended to calibrate the. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for 20 years. Designed for use in conjunction with the FastPack IP System for calculating the ratio of free/total PSA, expressed as a percentage (percent free PSA) The. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic system – in essence, a "lab in a box" that allows test results to be delivered with the accuracy of large laboratories but much more rapidly. Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Turn data collection into an experience with Typeform. Qualigen, Inc. Under the terms of an agreement announced in October 2020, Yi Xin will develop, manufacture. and international markets Sekisui Diagnostics to expand point of care testing portfolio with the FastPack® IP System from Qualigen Inc. Qualigen fastpack. , formerly Ritter Pharmaceuticals, Inc. The Company’s cancer therapeutics pipeline. FastPack IQCP Risk Assessment and Quality Control Plan. Buy Qualigens brand laboratory products online at best price in India. Sekisui owns approximately 15. Sekisui Diagnostics, Qualigen partnership, 10/16. (“Qualigen” or the “Company”), closed its Securities Purchase Agreement (dated December 16, 2020) with a single institutional investor for the purchase and sale for $12,000,000 of (i) 2,370,786 shares of Qualigen common stock, (ii) 1,000,000 pre-funded warrants (i. The Company is focused on the development and commercialization of therapeutic products for the treatment of cancer and infectiou s diseases, as well as development of its FastPack diagnostic platform. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. Qualigen's worldwide distributor for FastPack is Sekisui Diagnostics, a subsidiary of a multibillion-dollar Japanese chemical and technology company. Lower Limit of 23 ng/dL. o: qualigen therapeutics - withdrawn eua application submitted to fda in june 2020 for fastpack sars-cov-2 igg diagnostic test for covid-19 antibodies. Unlike tests at reference laboratories, the FastPack tests are conducted in physician. com - August 16 at 6:14 PM. Its pipeline includes AS1411, Aptamer Linked Anti Nucleolin (ALAN), Aptamer Linked Anti Nucleolin. The FastPack® IP Vitamin D Complete Kit includes required calibrator, controls and pre-treatment bundle. has developed SDSs for its products to help its customer's occupational health and […]. #25000043 / FastPack® IP Free T4 Kit (30) #25000040 / FastPack® IP Total PSA Kit (30) #25000041 / FastPack® IP Testo Kit (30) #25000068 / FastPack® IP Vitamin D Kit Complete. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today it has entered into a Material Evaluation and Option Agreement with the University College London (UCL) to advance development of and potentially expand toward future. (“Qualigen” or the “Company”), closed its Securities Purchase Agreement (dated December 16, 2020) with a single institutional investor for the purchase and sale for $12,000,000 of (i) 2,370,786 shares of Qualigen common stock, (ii) 1,000,000 pre-funded warrants (i. Qualigen, Inc. 26, 2021 / PRNewswire / - Qualigen, Inc. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. , is a biotechnology company. The Company's cancer therapeutics pipeline includes ALAN. , formerly Ritter Pharmaceuticals, Inc. Sekisui Diagnostics has entered into a strategic partnership with Qualigen to market and distribute Qualigen's FastPack IP System, the companies announced Tuesday. "I often tell people that Qualigen's FastPack® testing system saved my life, and that is why I am thrilled to join the Qualigen team," stated Mike Haynes. Qualigen Therapeutics, Inc. qualigeninc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. The FastPack PRO System is an upgraded version of Qualigen’s flagship FastPack IP rapid immunoassay diagnostic point-of-care system. , July 1, 2020 /PRNewswire/ -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN) ("Qualigen" or the "Company") announces it has submitted an official notification to the U. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. (QLGN) Use Authorization application which it had submitted to the US Food and Drug Administration in June 2020 for its FastPack® SARS-CoV-2 IgG diagnostic test. The FastPack ® PRO System is an upgraded version of Qualigen's flagship FastPack ® IP rapid immunoassay diagnostic point-of-care system. The FastPack System is an immunoassay testing system, which consists of the FastPack Analyzer and the FastPack test pouch, a single-use, disposable, foil packet which includes the FastPack reagent chemistry. , warrants to. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. FASTPACK TESTO IMMUNOASSAY: Classification: Radioimmunoassay, Testosterones And Dihydrotestosterone: Applicant: Qualigen, Inc. Carlsbad Biotech company Qualigen announced it has begun commercial shipments of its FastPack® SARS-CoV-2 IgG diagnostic test for COVID-19 antibodies. It had developed the Fastpack Testo Immunoassay. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. Qualigen's facility in Carlsbad, California is FDA and ISO. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic system - in essence, a "lab in a box" that allows test results to be delivered with the accuracy of large laboratories but much more rapidly. "I often tell people that Qualigen's FastPack® testing system saved my life, and that is why I am thrilled to join the Qualigen team," stated Mike Haynes. Timely, accurate immunoassay testing for physician offices. Qualigen Therapeutics, Inc. The Company's cancer. Recall for TOTAL PSA FASTPACK, Qualigen. The sale of this item may be subject to regulation by the U. Qualigen FastPack & Qualigen FastPack 7 15. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for 20 years. qualigen therapeutics inc - co believes there is no longer a viable business case for scale-up of test. (QLGN) Use Authorization application which it had submitted to the US Food and Drug Administration in June 2020 for its FastPack® SARS-CoV-2 IgG diagnostic test. Qualigen on LinkedIn, Twitter & YouTube. Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack® Diagnostics Products in China :: Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. The FastPack® IP System Control Kit is an assayed control for verification of the accuracy and precision of the FastPack® IP System when used for the quantitative determination of TSH, Free T4, Total PSA, Testosterone and hCG analytes. (Nasdaq: QLGN), a biotechnology company focused on developing novel therapies for the. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for 20 years. Qualigen has been producing high-quality diagnostic testing products for almost 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people's lives. Qualigen FastPack Immunoassay Analyzer, Enzyme for Sale. Qualigen Therapeutics CEO Issues Letter to Stockholders July 13 2020 - 08:00AM PR Newswire (US) Print CARLSBAD, Calif. source text: (https://bit. Create beautiful online forms, surveys, quizzes, and so much more. Used QUALIGEN Fastpack Blood Analyzer For Sale - DOTmed Listing #1885867: QUALIGEN FastPack IP System- Quantitative Immunoassay Analyzer. FastPack Immunology For Sale Auction. ’s Safety Data Sheets for its Products Safety Data Sheets (SDSs) provide a standardized listing of chemical and physical characteristics of a product, its potential health effects, and safety handling procedures in a workplace setting. Qualigen fastpack. related to the initiation of technology transfer of the FastPack system. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein inhibitor that. Sekisui Diagnostics, Qualigen partnership, 10/16. FastPack IP Free PSA chemiluminescent immunoassay is for the in-vitro quantitative determination of free prostate-specific antigen (free PSA) in human serum. 26, 2021 / PRNewswire / - Qualigen, Inc. Explore axonlab's photos on Flickr. Premarket Notification Section 5 1 0(k) FastPack® Vitamin D Immunoassay -,June 27, 2013 510(k) SUMMARY JUL 0 32013 This 5 10(k) Summary information is submitted in accordance with the requirements of 21. and international markets Sekisui Diagnostics to expand point of care testing portfolio with the FastPack® IP System from Qualigen Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, as well as maintaining and expanding its core FDA. Qualigen Therapeutics, Inc. Used QUALIGEN FastPack IP Blood Analyzer For Sale - DOTmed Listing #2653190: FastPack® IP System The FastPack® IP System is the only quantitative immunoassay analyzer available which features. Qualigen Therapeutics Submits Notification to FDA to Commence Distribution of its FastPack® COVID-19 Antibody Test. REAGENT, FASTPACK IP HCG (30KITS/BX) Features. The FastPack® IP Analyzer must be calibrated by the user to ensure that it is. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. October 2016— Sekisui Diagnostics and Qualigen announced a strategic partnership encompassing current business and future collaboration opportunities. The FastPack® line of FDA-cleared and CE-marked products have been used successfully in diagnostics since 2002. Qualigen Therapeutics Secures Option to Negotiate License for G-Quadruplex Anti-Cancer Technology from UCL GlobeNewswire Inc. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein inhibitor that. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. Qualigen, Inc. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic point-of-care system. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. Designed for use in conjunction with the FastPack IP System for calculating the ratio of free/total PSA, expressed as a percentage (percent free PSA) The. FastPack IP System is a fully automated quantitative immunoassay analyzer that provides results at the push of a button thanks to chemiluminescent technology. Qualigen Therapeutics, Inc. Analysts are initiating coverage of Qualigen Therapeutics (QLGN) with a valuation price tag of $10. 2013 Qualigen FastPack IP System in Westbury, NY, USA USD ($). (NASDAQ: QLGN) is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used in diagnostics for almost 20 years. , is a biotechnology company. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for 20 years. Qualigen Therapeutics Submits Notification to FDA to Commence Distribution of its FastPack® COVID-19 Antibody Test. Designed for use in conjunction with the FastPack IP System for calculating the ratio of free/total PSA, expressed as a percentage (percent free PSA) The. , now a subsidiary of Qualigen Therapeutics, Inc. Create beautiful online forms, surveys, quizzes, and so much more. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. In addition, Yi Xin will have the rights to manufacture and sell Qualigen's. Ref: 08000036. Our warranty excludes all consumable goods, eg. 4%) has begun commercial shipments of its FastPack SARS-CoV-2 IgG diagnostic test for COVID-19 antibodies. Qualigen Therapeutics Secures Option to Negotiate License for G-Quadruplex Anti-Cancer Technology from UCL Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack® Diagnostics Products in China. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including its flagship FastPack ® point-of-care immunoassay system and novel therapeutic technologies for treatment of cancers and infectious diseases. Qualigen, Inc. Try it for FREE. The FastPack ® PRO System is an upgraded version of Qualigen's flagship FastPack ® IP rapid immunoassay diagnostic point-of-care system. A resource for eye care professionals. Qualigen shall fully cooperate in the transition of such responsibilities to Sekisui, including by (i) technology transfer of all Qualigen documentation, designs, plans, bills of materials, etc. Qualigen Therapeutics to Host Business Update Conference Call on August 18, 2020. Qualigen Therapeutics, Inc. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. Upper Limit of 1600 ng/dL. Premarket Notification Section 5 1 0(k) FastPack® Vitamin D Immunoassay -,June 27, 2013 510(k) SUMMARY JUL 0 32013 This 5 10(k) Summary information is submitted in accordance with the requirements of 21. Qualigen, Inc. CARLSBAD, Calif. com - August 16 at 6:14 PM. The Company's cancer therapeutics pipeline includes ALAN. Qualigen Therapeutics, Inc. Qualigen has been producing high-quality diagnostic testing products for almost 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people's lives. Food and Drug Administration clearance for its FastPack Vitamin D Immunoassay, which can rapidly detect levels of the key vitamin in a patient's bloodstream. Select Qualigen Manual you need on this page. Qualigen Therapeutics (NASDAQ:QLGN) is up 46% premarket after submitting an official notification to the FDA to commence sales of its FastPack SARS-CoV-2 IgG test for COVID-19 antibodies in the U. Try it for FREE. Intended Use. Under the terms of an agreement announced in October 2020, Yi Xin will develop, manufacture and sell new generations of diagnostic test systems based on Qualigen's core FastPack® "laboratory in a pouch" technology, which includes high throughput diagnostic systems. Terms of Access to Qualigen, Inc. Qualigen Therapeutics Begins Shipping FastPack® COVID-19 Antibody Test Stockhouse. source text: (https://bit. Product Availability: USA, Europe, Middle East, Africa - Not available in all countries. The FastPack COVID-19 antibody test is a chemiluminescent microparticle test intended for the qualitative detection (i. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for almost 20 years. Qualigen has been producing high-quality diagnostic testing products for almost 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people's. Further, it expects to launch marketing for FastPack PRO SARS-CoV-2 IgG antibodies test in the current quarter, which could see "rapid uptake," contends Molloy. The Company's cancer therapeutics pipeline includes ALAN. FastPack® IP hCG is a chemiluminescent immunoassay for the in-vitro quantitative determination of human chorionic gonadotropin in human serum and plasma. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including novel therapeutic technologies for treatment of cancers and infectious diseases, as well as its flagship FastPack® point-of-care immunoassay system. This test has been submitted to the FDA for Emergency Use Authorization (EUA), and earlier this month the company submitted an official notification to the FDA of its plans to exercise its right to commence. Used QUALIGEN Fastpack Blood Analyzer For Sale - DOTmed Listing #1885867: QUALIGEN FastPack IP System- Quantitative Immunoassay Analyzer. It had developed the Fastpack Testo Immunoassay. , is a biotechnology company. 0 immunoassays (it being agreed that such consulting assistance will not require travel outside the USA by. Qualigen Therapeutics, Inc. Unlike tests at reference laboratories, the FastPack tests are conducted in physician. The Company is focused on the development and commercialization of therapeutic products for the treatment of cancer and infectious diseases, as well as development of its FastPack diagnostic platform. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for 20 years. Recent News. Qualigen, Inc. Under the terms of an agreement announced in October 2020, Yi Xin will develop, manufacture. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic system - in essence, a "lab in a box" that allows test results to be delivered with the accuracy of large laboratories but much more rapidly. Class 2 Device Recall Qualigen FastPack IP Vitamin D Immunoassay Kit Complete. The Company's cancer. * qualigen therapeutics (qlgn) - withdrawn eua application submitted to fda in june 2020 for fastpack sars-cov-2 igg diagnostic test for covid-19 antibodies * qualigen therapeutics inc (qlgn) - co believes there is no longer a viable business case for scale-up of test source text: (https://bit. Features One-Touch Operation in Delivering Values for. Practice Name (required) Contact Phone Number (required) Contact Email (required) FastPack® Lot Number (required) Analyzer Serial Number (required). Recent News. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. , a privately-owned company focused on the development and commercialization of novel therapeutic products for the treatment of cancer and infectious diseases, as well as expansion of its flagship FastPack® diagnostic platform, announced today the issuance of U. Product Availability: USA, Europe, Middle East, Africa - Not available in all countries. CARLSBAD, Calif. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including novel therapeutic technologies for treatment of cancers and infectious diseases, as well as its flagship FastPack® point-of-care immunoassay system. Qualigen Therapeutics, Inc. Unlike tests at reference laboratories, the FastPack tests are conducted in physician. announced that it has received U. 2042 CORTE DEL NOGAL SUITE B Carlsbad, CA 92011 -1438 : Contact: Michael S Poirier: Correspondent: Michael S Poirier Qualigen, Inc. announces it has entered into an agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd, of Suzhou, China to develop, manufacture and sell new generations of diagnostic test systems based on Qualigen's core FastPack "laboratory in a pouch" technology. The FastPack® IP Testosterone Immunoassay is designed for use with the FastPack® IP System. The Company's cancer. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein inhibitor that. In depth view into Qualigen Therapeutics Price to Book Value including historical data from 2015, charts, stats and industry comps. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. Serial Number: 75399007. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic system - in essence, a "lab in a box" that allows test results to be delivered with. Contact Technical Support at [email protected] The firm, Qualigen, sent an "URGENT: PRODUCT RECALL" letter dated 7/5/2017 to its customers by email or fax on 07/07/2017. The FastPack® IP Vitamin D Complete Kit includes required calibrator, controls and pre-treatment bundle. It is estimated that thousands of lives have been saved by Qualigen's diagnostics. The FastPack ® System is a proprietary diagnostics platform launched by Qualigen in 2001. The customers were instructed to stop using the products immediately; discard. Try it for FREE. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. Food and Drug Administration and state and local regulatory agencies. Qualigen, Inc. FastPack IP System is a fully automated quantitative immunoassay analyzer that provides results at the push of a button thanks to chemiluminescent technology. Carlsbad, California, United States. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. By continuing to use our service, you agree to our use of cookies. Qualigen Therapeutics, Inc. 3) in support of Licensee's research, development and optimization of the identified first five FastPack 2. Since receiving an elevated PSA test result using a FastPack immunoassay test at a 2008 Hall of Fame event sponsored by Qualigen and the American Urological Association, Mr. (“Qualigen” or the “Company”), closed its Securities Purchase Agreement (dated December 16, 2020) with a single institutional investor for the purchase and sale for $12,000,000 of (i) 2,370,786 shares of Qualigen common stock, (ii) 1,000,000 pre-funded warrants (i. Qualigen Therapeutics, Inc. It had developed the Fastpack Testo Immunoassay. - 3/1/2021 8:30:00 AM Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack® Diag. The protein SHBG is an important biomarker used in diagnosis and treatment of certain conditions. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. Filed: December 2, 1997 kits composed of clear cartridges pre-filled with diagnostic reagents into which fluids are introduced and through which… Owned by: QUALIGEN, INC. About Qualigen Therapeutics, Inc. Two levels of control are available to allow performance monitoring within the clinical range. Results in 12 minutes. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack (R) System, which has been used successfully in diagnostics for 20 years. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. (Nasdaq: QLGN), a biotechnology company focused on developing novel therapies for the. The Company's subsidiary is Qualigen, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. Performs a test by automatically mixing and moving the sample and reagents within the pack, with results in 12. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. Lexington, MA August 2, 2016: Sekisui Diagnostics has significantly expanded its point of care (POC) diagnostics product line through a recent partnership agreement with Qualigen, Inc. Check out our extensive catalog of New & Used Qualigen FastPack Immunoassay Analyzer, Enzyme devices. The Qualigen-developed FastPack IP System is a fully automated blood analyser which generates rapid, quantitative immunoassay results with the push of a button for important biomarkers in the areas of cancer, metabolic disorders, hormone regulation and pregnancy management. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, as well as maintaining and expanding its core FDA. com - August 16 at 6:14 PM. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Qualigen Therapeutics Inc. Upper Limit of 1600 ng/dL. * qualigen therapeutics (qlgn) - withdrawn eua application submitted to fda in june 2020 for fastpack sars-cov-2 igg diagnostic test for covid-19 antibodies * qualigen therapeutics inc (qlgn) - co believes there is no longer a viable business case for scale-up of test source text: (https://bit. Qualigen, Inc. Turn data collection into an experience with Typeform. Find the latest Qualigen Therapeutics, Inc. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. Unlike tests at reference laboratories, the FastPack tests are conducted in physician. Qualigen, Inc. Qualigen Therapeutics, Inc. It had developed the Fastpack Testo Immunoassay. Yi Xin will also have the right to sell its new generations of FastPack-based diagnostic test systems throughout the world (but not to or toward current customers of the Company’s existing generations of FastPack products); any such non-China sales would, until May 1, 2022, need to be through Sekisui. October 2016— Sekisui Diagnostics and Qualigen announced a strategic partnership encompassing current business and future collaboration opportunities. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic system - in essence, a "lab in a box" that allows test results to be delivered with. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. announces it has entered into an agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd, of Suzhou, China to develop, manufacture and sell new generations of diagnostic test systems based on Qualigen’s core FastPack “laboratory in a pouch” technology. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein inhibitor that. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for 20 years. Includes FastPack 43-R Analyzer with Star SP298 POS Dot-Matrix Receipt Printer; Power Supply Units. Try it for FREE. FastPack® IP hCG is a chemiluminescent immunoassay for the in-vitro quantitative determination of human chorionic gonadotropin in human serum and plasma. The Company is focused on the development and commercialization of therapeutic products for the. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. Qualigen is a biopharmaceutical company developing novel treatments for cancer and infectious diseases while continuing and expanding its FDA approved FastPack® System. Qualigen FastPack Immunoassay Analyzer, Enzyme for Sale. Qualigen Therapeutics, Inc. Qualigen FastPack IP System Pdf-Bedienungsanleitungen. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein. Qualigen products. Turn data collection into an experience with Typeform. Qualigen Therapeutics Releases FastPack® SARS-CoV-2 Antibody Diagnostic Test to University of Louisville to Conduct Validation Studies Stockhouse. Qualigen Therapeutics, Inc. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein inhibitor that. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack ® System, which has been used successfully in diagnostics for 20 years. Ref: 08000036. The FastPack ® PRO System is an upgraded version of Qualigen's flagship FastPack ® IP rapid immunoassay diagnostic point-of-care system. Qualigen Therapeutics Announces Inclusion in Russell Microcap® Index GlobeNewswire Inc. The Company’s cancer therapeutics pipeline. (Nasdaq: QLGN) announces it has entered into an agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd, of Suzhou, China to develop, manufacture and sell new. (QLGN) Use Authorization application which it had submitted to the US Food and Drug Administration in June 2020 for its FastPack® SARS-CoV-2 IgG diagnostic test. Recent News. Lexington, MA August 2, 2016: Sekisui Diagnostics has significantly expanded its point of care (POC) diagnostics product line through a recent partnership agreement with Qualigen, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. Qualigen shall provide to Licensee a reasonable level of consulting assistance from Qualigen personnel (as authorized in Section 6. Qualigen products. Results in 12 minutes. K994419 Total PSA FastPack¿ Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Check out this company, QUALIGEN therapeutics- ticker QLGN, which is working on the treatment of infectious diseases and CANCER! QLGN is waiting for EUA's approval for their covid-19 test kit FASTPACK. Timely, accurate immunoassay testing for physician offices. The milestone event pertained to the initiation of technology transfer of Qualigen's core FastPack® System, a rapid and highly accurate immunoassay testing system consisting of the FastPack. Create beautiful online forms, surveys, quizzes, and so much more. The Company is focused on the development and commercialization of therapeutic products for the treatment of cancer and infectiou s diseases, as well as development of its FastPack diagnostic platform. com - August 14 at 7:09 PM. Qualigen’s only products that are currently commercially available are its FastPack System diagnostic instruments and test kits. Serial Number: 75399007. Premarket Notification Section 5 1 0(k) FastPack® Vitamin D Immunoassay -,June 27, 2013 510(k) SUMMARY JUL 0 32013 This 5 10(k) Summary information is submitted in accordance with the requirements of 21. , a privately owned company that provides rapid, easy to use, fully quantitative diagnostic testing solutions, has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FastPack Vitamin D Immunoassay for use on its proprietary FastPack System for the rapid determination of vitamin D status. Qualigen Therapeutics Revenue (TTM): 4. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. Used QUALIGEN Fastpack Blood Analyzer For Sale - DOTmed Listing #1885867: QUALIGEN FastPack IP System- Quantitative Immunoassay Analyzer. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. com - August 16 at 6:14 PM. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well. Performs a test by automatically mixing and moving the sample and reagents within the pack, with results in 12. The FastPack System is an immunoassay testing system, which consists of the FastPack Analyzer and the FastPack test pouch, a single-use, disposable, foil packet which includes the FastPack reagent chemistry. (QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today that according to a preliminary list of additions posted June 4 it will be added to the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective on June 28, 2021. Qualigen Therapeutics, Inc. Qualigen is a biopharmaceutical company developing novel treatments for cancer and infectious diseases while continuing and expanding its FDA approved FastPack® System. Qualigen, Inc. , formerly Ritter Pharmaceuticals, Inc. Ref: 08000036. The FastPack® System is a proprietary diagnostics platform launched by Qualigen in 2001. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics since 2002. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for almost 20 years. Qualigen Therapeutics, Inc. About Qualigen Therapeutics, Inc. ’s Safety Data Sheets for its Products Safety Data Sheets (SDSs) provide a standardized listing of chemical and physical characteristics of a product, its potential health effects, and safety handling procedures in a workplace setting. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated gold nanoparticle cancer drug candidate that targets various cancers; AS1411 for treating viral-based infectious diseases; RAS-F3, a small-molecule RAS oncogene protein-protein. The FastPack® PRO System is an upgraded version of Qualigen's flagship FastPack® IP rapid immunoassay diagnostic point-of-care system. 2013 Qualigen FastPack IP System in Westbury, NY, USA USD ($). Includes FastPack 43-R Analyzer with Star SP298 POS Dot-Matrix Receipt Printer; Power Supply Units. , formerly Ritter Pharmaceuticals, Inc. com use cookies on this site. CPT Code: 84403. The move will expand Sekisui's point of care testing portfolio and Sekisui will assume all. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Qualigen's FastPack IP SHBG Immunoassay receives US FDA approval: Carlsbad, California Thursday, January 31, 2019, 16:00 Hrs [IST] Qualigen, Inc, a privately-owned company that provides novel diagnostic and therapeutic technologies for the treatment of cancer and infectious diseases, has received clearance from the US Food and Drug Administration for its FastPack IP Sex Hormone Binding. Qualigen, Inc. The control is provided in liquid form for convenience. 10/8/2020 9:04:56 AM Qualigen Enters Into Commercialization Deal For Its FastPack Diagnostic Products In China 9/24/2020 6:29:23 AM Pre-market Movers In Healthcare Sector: BIOL, OTIC, ANPC, CEMI, LPCN, NAOV. Qualigen Therapeutics, Inc. , a privately-owned company focused on the development and commercialization of novel therapeutic products for the treatment of cancer and infectious diseases, as well as expansion of its flagship FastPack® diagnostic platform, announced today the issuance of U. ("Yi Xin"), of Suzhou, China, for Yi Xin to develop, manufacture and sell new generations of diagnostic test systems based on our core FastPack technology. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. One-touch operation for increased efficiency. Qualigen Therapeutics, Inc. Create beautiful online forms, surveys, quizzes, and so much more. Food and Drug Administration clearance for its FastPack Vitamin D Immunoassay, which can rapidly detect levels of the key vitamin in a patient's bloodstream. (Nasdaq: QLGN), a biotechnology company focused on developing novel therapies for the. source text: (https://bit. Qualigen FastPack IP System. Ref: 08000036. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic point-of-care system. , a biotechnology company, develops novel therapeutic products for the treatment of cancer and infectious diseases. Qualigen FastPack & Qualigen FastPack 7 15. It offers FastPack, a rapid diagnostic testing system; ALAN, a DNA coated g. Quantitative Measurement of total testosterone. By continuing to browse you accept these cookies. (QLGN) stock quote, history, news and other vital information to help you with your stock trading and investing. Qualigen's SARS-CoV-2 IgG immunoassay, for use with its new FastPack PRO System point-of-care diagnostic instruments, is a chemiluminescent microparticle test intended for the qualitative. Be prepared to complete this exercise (about 40 questions). Upper Limit of 1600 ng/dL. The letter described the product, problem and actions to be taken. Thursday, 07/02/20 09:00:28 AM. Turn data collection into an experience with Typeform. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic system - in essence, a "lab in a box" that allows test results to be delivered with. Qualigen Therapeutics, Inc. Sekisui Diagnostics is now the exclusive worldwide distributor of the FastPack IP System, Qualigen's innovative. - 3/1/2021 8:30:00 AM Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack® Diag. com) is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, using similar core nanoparticle coating technology from its FDA-approved FastPack ® System, which has been used successfully in diagnostics for over 15 years. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. Kabla Clinical DX es la división especializada en Dispositivos de Diagnóstico para uso In Vitro Profesional - incluyendo Pruebas. Sekisui Diagnostics to market Qualigen's FastPack IP System: Lexington, Massachusetts Thursday, August 4, 2016, 13:00 Hrs [IST] Sekisui Diagnostics has significantly expanded its point of care (POC) diagnostics product line through a recent partnership agreement with Qualigen, Inc. Features One-Touch Operation in Delivering Values for. It had developed the Fastpack Testo Immunoassay. Yi Xin will also have the right to sell its new generations of FastPack-based diagnostic test systems throughout the world (but not to or toward current customers of the Company’s existing generations of FastPack products); any such non-China sales would, until May 1, 2022, need to be through Sekisui. Qualigen, Inc. Try it for FREE. Qualigen's SARS-CoV-2 IgG immunoassay, for use with its new FastPack PRO System point-of-care diagnostic instruments, is a chemiluminescent microparticle test intended for the qualitative. 10/8/2020 9:04:56 AM Qualigen Enters Into Commercialization Deal For Its FastPack Diagnostic Products In China 9/24/2020 6:29:23 AM Pre-market Movers In Healthcare Sector: BIOL, OTIC, ANPC, CEMI, LPCN, NAOV. com use cookies on this site. Qualigen Therapeutics, Inc. Use the search box or links above to find what you're looking for. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. com - August 14 at 7:09 PM. , formerly Ritter Pharmaceuticals, Inc. In October 2020, the company announced that Yi Xin will develop, manufacture, and sell new generations of diagnostic test. Qualigen Therapeutics Submits Notification to FDA to Commence Distribution of its FastPack® COVID-19 Antibody Test. Qualigen Therapeutics, Inc. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. , we entered into a Technology Transfer Agreement dated as of October 7, 2020 with Yi Xin Zhen Duan Jishu (Suzhou) Ltd. Sekisui Diagnostics, Qualigen partnership, 10/16. Most orders placed before 8 PM Eastern Time process the same day!. One-touch operation for increased efficiency. Sekisui Diagnostics has assumed commercial activities and distribution management for the FastPack IP System and associated products in U. Qualigen has been producing high-quality diagnostic testing products for almost 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help. Same Antigen Used in. Qualigen Therapeutics (NASDAQ:QLGN) has announced that it has withdrawn the emergency use authorization application submitted to the FDA for FastPack COVID-19 diagnostic test. Qualigen Therapeutics Secures Option to Negotiate License for G-Quadruplex Anti-Cancer Technology from UCL. Qualigen Therapeutics, Inc. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including its flagship FastPack ® point-of-care immunoassay system and novel therapeutic technologies for treatment of cancers and infectious diseases. CARLSBAD, Calif. The Company is focused on the development and commercialization of therapeutic products for the. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test. Qualigen Therapeutics Announces Completion of Milestone Related to the License and Technology Transfer of its FastPack® Diagnostics Products in China PR Newswire - PRF 09:03 AM ET Tuesday, Jan 05, 2021. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core. FastPack®'s big advantage over research in large commercial labs. related to the initiation of technology transfer of the FastPack system. CPT Code: 84403. (Nasdaq: QLGN) announces it has entered into an agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd, of Suzhou, China to develop, manufacture and sell new. In addition, Yi Xin will have the rights to manufacture and sell Qualigen's. Our Approach Qualigen is a biotechnology company focused on the development and commercialization of therapeutic products for the treatment of cancer and viral diseases, as well as expansion of its flagship FastPack® diagnostic platform. In addition, Yi Xin Zhen Duan Jishu (Yi Xin) will have the rights to manufacture and sell Qualigen’s […].