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The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.Aytu BioScience, Inc. COVID-19 lgG/lgM Rapid Test CassetteThe COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.

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