To date, we ’ ve issued 37 emergency use authorizations (EUAs) for #COVID19 diagnostic tests. Most recently, EUAs were issued to Mount Sinai Laboratory ’ s COVID-19 ELISA IgG Antibody Test & Maccura Biotechnology (USA) LLC ’ s SARS-CoV-2 Fluorescent PCR Kit. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   …

To date, we’ve issued 37 emergency use authorizations (EUAs) for #COVID19 diagnostic tests. Most recently, EUAs were issued to Mount Sinai Laboratory’s COVID-19 ELISA IgG Antibody Test & Maccura Biotechnology (USA) LLC’s SARS-CoV-2 Fluorescent PCR Kit. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd …

Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news