emergency use authorization
Amazon, Diabetomics Get FDA Emergency Use Authorizations for Coronavirus Tests
The FDA granted EUA to Amazon subsidiary STS Lab Holdco for the Amazon Real-Time RT-PCR DTC Test and the Diabetomics CovAb SARS-CoV-2 Ab Test.
Thermo Fisher Gets FDA Emergency Use Authorization for Pooled Sample SARS-CoV-2 Test Kit
The RT-PCR-based kit is designed to detect SARS-CoV-2 nucleic acid in pooled samples containing up to five individual nasal swab specimens.
DiaSorin, Salofa Get FDA Emergency Use Authorization for SARS-CoV-2 Assays
DiaSorin's test is designed to detect IgG antibodies against the virus, while Salofa's assay detects the virus' nucleocapsid protein antigen.
Phosphorus Diagnostics Gets FDA EUA for Direct-to-Consumer Coronavirus Test, Sample Collection Kit
The saliva-based assay is a nonprescription version of the Phosphorous COVID-19 RT-qPCR Test, which received Emergency Use Authorization from the FDA last year.
Zeus Scientific Gets FDA Emergency Use Authorization for SARS-CoV-2 Total Antibody Test
Late last year, the company received Emergency Use Authorization from the FDA for a test that detects IgG antibodies against SARS-CoV-2.
Apr 26, 2021