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Healgen | COVID-19 Rapid Antibody Test Kit (25 Tests)
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Healgen COVID-19 IgG/IgM Rapid Antibody Test - Contains 25 Tests!
For Laboratory & Certified Medical Professional Use Only - MUST HAVE CLIA LICENSE!
*Granted Emergency Use Authorization by the FDA on 5/29/2020*
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.
This Rapid Test Kit is to be read at 10 minutes allowing rapid determination of IgG and/or IgM presence. The COVID-19 Rapid Test Kit is both sensitive and specific for the IgG and IgM antibodies.
This product is FDA/EUA Approved.
FDA Approval Letter: FDA Letter
Product Insert: View or Print Here
Click here for Fact Sheet for Healthcare Provider
Click here for Fact Sheet for Recipients
Disclosure:
• 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; and
• 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.
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.
Quantity: 25 tests per box
Availability: Subject to availability
Product Code: GCCOV-402A HG
Call us at 419-852-2464 or email sales@testkitsathome.com for pricing! DO NOT PLACE ORDER ONLINE!
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