Description
COVID-19 Antibody Rapid Detection Kit by Healgen Scientific, LLC
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals. Non-refundable. (excludes lancets, and alcohol pads).
PLEASE REVIEW BELOW BEFORE PLACING YOUR ORDER
1. Not for Fingerstick use
2. Review two fact sheet below before ordering
3. Review the warnings below before ordering:
Warning
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.
4. Not for at home use at all.
Please review all the FDA approved factsheet, IFU, and EUA letter for your reference before placing your order:
EUA200056 Healgen-Fact sheet for healthcare providers
EUA200056 Healgen-Fact sheet recipients
