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NEW YORK — The US Food and Drug Administration on Friday granted Emergency Use Authorization for Healgen Scientific's rapid immunoassay for SARS-CoV-2.

The COVID-19 IgG/IgM Rapid Test Cassette uses lateral flow technology to detect and differentiate immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies against SARS-CoV-23 in venous whole blood, plasma, and serum. The test provides results in 10 minutes and is authorized for use by laboratories CLIA-certified to perform moderate- or high-complexity tests.

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