emergency use authorization
Mammoth Biosciences High-Throughput CRISPR-Based COVID Test Gets FDA EUA
The high-throughput test combines CRISPR technology with an automated liquid handling platform from Agilent.
FDA Grants Emergency Use Authorization for Premier Medical COVID-19 Test
The PCR-based test uses nasal swab specimens collected with the INeedaCOVID19Test.com Self Collection Kit.
FDA Unveils Draft Guidance for SARS-CoV-2 Test Developers to Gain Full Regulatory Approval
The agency recommends manufacturers develop a transition implementation plan addressing how to deal with devices that have already been distributed.
Tide Labs Resolves Issue With Molecular SARS-CoV-2 Test to Detect Omicron Variant
The US Food and Drug Administration reissued the test's Emergency Use Authorization last week after the company modified the assay.
FDA Grants Emergency Use Authorization for UCSD Molecular COVID-19 Test
The PCR-based test was developed by the UCSD BCG Expedited Covid Identification Environment (EXCITE) Lab.