Fastep® Finger Stick COVID-19 Rapid Test
The FaStep COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Results in 15 minutes
IgM/IgG Rapid Test Kit
- CLIA WAIVED for Finger Stick
- FDA EUA Approved
- Box of 20 Test Kits
Included:
- 20 Test Cassettes
- 20 Lancets
- 20 Pipettes
- 20 Individual Buffers
- 20 Alcohol Prep Pads
The COVID-19 IgG/IgM
- CLIA WAIVED
- FDA EUA Approved for Finger Stick
- Individually packaged Buffer Solutions
EC Declaration of Conformity (554.04 kB)
Instructional Manual (1.32 MB)
FDA Emergency Use Authorization - Sept 23 2020 (355.59 kB)
Face Sheet for Recipients (256.45 kB)
Fact Sheet for Healthcare Providers (226.58 kB)
· 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.