BioShield 2019-nCoV Total Antibody ELISA Kit

Bio-Shield 2019-nCoV Total Immunoglobulins, is a semi-quantitative ELISA test for the determination of IgA, IgM, IgG antibodies against SARS-CoV-2 in human serum or plasma (Heparin, EDTA or Citrate) specimens.

This test is allowed to be marketed under policy D of the FDA Policy for Diagnostic Tests for Coronavirus Disease 2019 during the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff document issued March 16, 2020.



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