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Fastep® Finger Stick COVID-19 Rapid Test

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$375.00
$200.00
$200.00
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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.

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  • ABOUT
    • Who We Are
    • Leadership
    • Clients
  • Expertise
    • Faith Based Development
    • Small Business Incubator
    • Government Contracting
  • Community
  • Careers
  • Contact