The US Food and Drug Administration this week granted separate Emergency Use Authorizations for a respiratory panel RT-PCR test from Laboratory Corporation of America and a COVID-19 RT-PCR test from Nexus Medical Labs.
On Monday, The US Food and Drug Administration issued an Emergency Use Authorization to Laboratory Corporation of America's Seasonal Respiratory Virus RT-PCR DTC test for use without a prescription by individuals with symptoms of COVID-19.
The US Food and Drug Administration earlier this month granted Emergency Use Authorization for Abbott's ID Now COVID-19 2.0 rapid point-of-care test.
Danaher subsidiary Cepheid announced on Thursday that its Xpert Xpress CoV-2 plus test has received Emergency Use Authorization from the US Food and Drug Administration.
Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.
C2i Genomics launches minimal residual disease test across Europe after clearing regulatory hurdles in the EU, UK, and Switzerland.
On April 6, it was reported that the Rapid SARS-CoV-2 Antigen Test Card produced by Xiamen Boson Biotech Co., Ltd. has obtained the FDA Emergency Use Authorization (EUA).
Jinan Babio Biotechnology Co., Ltd. recently received an official notification from the EU Notified Body for its self-tested novel coronavirus antigen detection product, and subsequently obtained the CE certification issued by PCBC.
On March 23, 2022, AutoBio’s SARS-CoV-2 Ag Rapid Home Test successfully passed the European clinical assessment and the audit of the notified institution, obtained the EU CE certificate.
The US Food and Drug Administration this week granted separate Emergency Use Authorizations for three direct-to-consumer SARS-CoV-2 tests from Quest Diagnostics, as well as a home sample collection kit for use with the tests.
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