Healgen COVID-19 IgG/IgM Rapid Antibody Test

*Granted Emergency Use Authorization by the FDA on 5/29/2020*

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.

This Rapid Test Kit is to be read at 10 minutes allowing rapid determination of IgG and/or IgM presence. The COVID-19 Rapid Test Kit is both sensitive and specific for the IgG and IgM antibodies.

• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• 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; and
• 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.

Quantity: 25 tests per box

Availability: Subject to availability
Product Code: GCCOV-402A HG

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