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OPTI Medical Systems Gets CE Mark For OPTI SARS-CoV-2 RNA PCR Test Kit

OPTI Medical Systems Inc., a subsidiary of IDEXX Laboratories Inc. (IDXX), said 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.

In addition, the FDA has granted Emergency Use Authorizatio 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.

The OPTI SARS-CoV-2 RT-PCR test kit uses real-time reverse transcription polymerase chain reaction (RT-PCR) technology and is designed to provide results in about 2-3.5 hours.

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