Covid-19 IgG/IgM Rapid Test Kit FDA Statements

FDA STATEMENTS

Medsential's Point of Care Rapid Test Offering:

Information For Use

Quick Reference Guide

FDA Letter of Authorization

Fact Sheet for Healthcare Providers

Face Sheet for Patients

  • 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.

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