The US Food and Drug Administration this week granted Emergency Use Authorization for a molecular SARS-CoV-2 test from Predicine.
Israeli diagnostics firm Nucleix said on Wednesday that it has expanded the European Union label indication of its Bladder EpiCheck urothelial cancer test.
The US Food and Drug Administration announced after the close of the markets on Friday that it has issued Emergency Use Authorization (EUA) for Laboratory Corporation of America's VirSeq SARS-CoV-2 NGS Test.
Monkeypox is a zoonotic disease that was first identified in monkeys in 1958. Although it is named monkeypox virus, its primary host is rodents such as mice and squirrels, and its opportunistic host is primates, humans.
On May 23, 2022, Autobio Diagnostics Co., Ltd. announces CE mark for AutoMeloc Monkeypox nucleic acid detection kit (PCR-fluorescent probe method).
On May 19, the COVID-19 Antigen Rapid Test (colloidal gold method) independently developed by Guangzhou Weimi Bio-Tech Co., Ltd (“Weimi Bio-Tech”) successfully obtained the EU CE certificate.
Illumina said on Tuesday that it has added a companion diagnostic indication to its in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test.
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.
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