News
CE Mark for OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2,.- Opti Medical Systems
OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. announced that it has received the CE mark certification in the European Union for its OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19. This announcement follows earlier validation of the test by the Institut Pasteur of France as well as Emergency Use Authorization (EUA) by the FDA.
Additionally, the FDA has granted EUA for the new OPTI DNA/RNA Magnetic Bead Kit for nucleic acid extraction from respiratory samples to be used with the OPTI SARS-CoV-2 RT-PCR test kit, which enables OPTI Medical Systems to provide laboratories with a complete OPTI Medical Systems-manufactured workflow solution for COVID-19 testing.
Condition: Coronavirus/COVID-19 Infection
Type: drug
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