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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The ID Now COVID-19 test is the second assay from the company to receive EUA from the FDA, following the same designation issued to the Abbott RealTime SARS CoV-2.

The NxTag CoV Extended Panel is a multiplex PCR test that uses the company's bead-based NxTag technology to detect coronavirus in nasopharyngeal swab specimens.

Sysmex anticipates delivering the kit to Japanese medical institutions this month for diagnosis of the SARS-CoV-2 infection.

The AvellinoCoV2 real-time PCR test is designed for the detection of nucleic acid from SARS-CoV-2 from nasopharyngeal and oropharyngeal swab specimens.

The anti-SARS-CoV-2 antibodies for classes IgA and IgG are two of the first antibody detection tests to receive CE making and be made available for SARS-CoV-2 testing.