COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to COVID-19 in human serum, plasma or whole blood as an aid in the diagnosis of primary and secondary COVID-19 infections.
COVID-19(Corona Virus Disease) is an infectious disease caused by the most recently discovered coronavirus. The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some people become infected but don't develop any symptoms and don't feel unwell. People can catch COVID-19 from others who carry the virus. The disease can spread from person to person through small droplets from the nose or mouth when a person with COVID-19 coughs or exhales. The incubation period for COVID-19 generally ranges from 1-14 days.
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
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.
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 bloo
Subscribe to our newsletter
A short sentence describing what someone will receive by subscribing