COVID-19 Antibody Rapid Test Device
Detect the presence of SARS-CoV-2 IgM and IgG antibodies instantly from a whole blood sample collected from a minimally-invasive fingerstick blood collection process.
FDA EUA Point of Care COVID-19 Test
This test is authorized for use with point-of-care finger stick whole blood specimens. Father IgM/IgG for COVID-19 within 15 minutes at the point of care/collection. Patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation are authorized to use the COVID-19 rapid testing solution.
Find out how the COVID-19 testing solution can work for your healthcare practice or to learn more about how to obtain the correct certification contact us at: (757) 398-8400 or email@example.com
- 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 blood.