Covid-19 IgG/IgM Rapid Test Kit FDA Statements

FDA STATEMENTS

Medsential's Point of Care Rapid Test Offering:

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
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 andor 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.