Healgen COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
- 25 tests per box.
- FDA EUA.
- Easy to use, results in minutes.
- For medical professional use only ** VERIFICATION REQUIRED **
- For use in CLIA moderate- and highly-complex labs.
- Reimbursement/Billing Code (CPT) 86328QW.
** Call now to order 888-562-5852 **
FACT SHEET (TEST RECIPIENTS)
FACT SHEET (HEALTHCARE PROVIDERS)
IFU (INSTRUCTIONS FOR USE) (PACKAGE INSERT)
FDA EMERGENCY USE AUTHORIZATION (EUA) LIST
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 test provides only a preliminary test result and is for professional use only.
This is a blood test that will screen for antibodies to help determine if you have been exposed to the virus. This test is highly sensitive and specific.
TEST PROCEDURE
MATERIALS SUPPLIED
25 sealed pouches each containing test cassette and dropper
1 bottle of buffer solution
1 package insert
** Call now to order 888-562-5852 **
- 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; 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.
- 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.
