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Monocent Inc, Receives Authorization From COFEPRIS (Mexico) And INVIMA (Colombia), For Their US-Manufactured, CE Marked, Highly Accurate, Easy-To-Use, 15-Minute, COVID-19 Antigen Test


Published: Mar 17, 2021
 
CHATSWORTH, Calif., March 17, 2021 /PRNewswire/ Monocent Inc., (Monocent) is pleased to announce the COFEPRIS authorization of their SARS-CoV2 Antigen Rapid test System for detection of COVID-19 infection. The Monocent antigen test is a lateral flow test that provides results in just 15-minutes, without the use of any laboratory equipment. A collection of 3
rd party clinical evaluation studies from US, UK, Mexico, Columbia, India and China have shown the test to have 98% sensitivity and 100% specificity when compared to RT-PCR, making it ideal for large-scale, cost effective testing programs. 
The Monocent Antigen Test is one component of Monocent s comprehensive COVID-19 testing solution. The test is paired with a complimentary, cutting-edge, HIPAA compliant technology platform, Rymedi. Rymedi s intuitive software will allow test administrators to securely send results to an individuals mobile wallet and display as a scannable Q ....

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FDA grants EUA to BD's SARS-CoV-2/Flu assay


FDA grants EUA to BD s SARS-CoV-2/Flu assay
FDA grants EUA to BD s SARS-CoV-2/Flu assay
15 February 2021 | News
The BD® SARS-CoV-2/Flu assay is run on the BD MAX™ System and distinguishes between SARS-CoV-2 and Influenza A+B, providing a positive or negative result for each virus using a single specimen
Source: PR Newswire
BD (Becton, Dickinson and Company), a leading global medical technology company, has announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) for a new molecular diagnostic test for both SARS-CoV-2 and Influenza A+B that can return results in two to three hours. The new test also has been CE marked to the IVD Directive (98/79/EC). ....

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