|Dimensions||0.5 × 0.6 × 0.3 cm|
Healgen Covid Test Kits
$15.00 / Each
Note: An NPI number (National Provider Identifier) will be required to purchase this product.
Included in each kit:
- 25 kits
- 25 pipettes per box (inside the cassette pack)
- 1 large buffer per kit
- Package insert
- FDA Emergency Use Authorization (EUA)
- Rapid results within 2 – 10 minutes
- Sold in packs of 25
- Shelf life of up to 24 months from manufacture date
- Test to be performed in a CLIA moderate- or high-complexity setting
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.
* The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19.