COVID 19 IgG IgM Rapid Antibody Test Kit

Description

FDA Emergency Use Authorized COVID-19 “Coronavirus” IgG/IgM Rapid Antibody Test Kit

Additional information:

This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test 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 Act, 21 U.S.C. $360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

CPT Code:  86328

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
(Coronavirus disease [COVID-19])

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