The US Food and Drug Administration last week granted Emergency Use Authorization for Premier Medical Laboratory Services' Diversified Medical Healthcare SARS-CoV-2 Assay.
The COVID-19 Antigen Home Test manufactured by Assure Tech has been validated by laboratory and clinical studies to meet FDA standards and has been granted EUA. This means that the product can be marketed in the USA and in countries that recognise FDA EUA approval.
The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for a molecular COVID-19/flu test from Lucira Health.
The US Food and Drug Administration said on Tuesday that it has granted Emergency Use Authorization for Roche's molecular monkeypox test.
The US Food and Drug Administration this week granted Emergency Use Authorization for Nanobiosym Precision Testing Services' Nano Test for COVID-19.
Becton Dickinson and CerTest Biotec have made a PCR assay for monkeypox virus available commercially in the U.S. and other markets worldwide.
The US Food and Drug Administration said on Tuesday that it is updating its policy on Emergency Use Authorizations for COVID-19 tests and limiting its review of new submissions.
The US Department of Health and Human Services announced on Wednesday that it has authorized the Food and Drug Administration to issue emergency use authorizations for monkeypox tests.
Recently, four products of Tianlong Science and Technology, including E. coli, Salmonella, Staphylococcus aureus, and Listeria monocytogenes DNA detection kits, have obtained EU CE certification.
Meridian Bioscience said on Friday that the Emergency Use Authorization for its Revogene SARS-CoV-2 molecular test has been reissued by the US Food and Drug Administration.
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