CareStart™ COVID-19 IgM/IgG
Is intended for use as an aid in identifying and monitoring individuals’ previous infection history and immune response to COVID-19. This rapid test detects and differentiates IgM/IgG antibodies specific to SARS-CoV-2.
The CareStart™ COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), and venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA).
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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