Coronavirus COVID-19 IgG/IgM Rapid Antibody Test Kit (25 Tests Per Box)

$400.00

10 in stock

SKU: Antibody-CV2 Categories: ,

Description

This test has been authorized by FDA under a 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

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 the 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.

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use.

Not for the screening of donated blood.

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
This Rapid COVID-19 Test Kit helps facilitates timely patient treatment decisions by providing results onsite in 5 – 10 minutes. This product is a simple, time-saving procedure that contains all the necessary reagents to detect the presence of the IgM and IgG antibodies. This COVID-19 Rapid Test Kit is also highly sensitive and specific with an overall agreement of ~97%.

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.

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

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