FaStep COVID-19 Coronavirus Antibody Test Kit FDA EUA Authorized CLIA Waived 20/Box

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SKU:
AZ COVID-19 P FSTP
$140.00

Description

FaStep Covid-19 FDA POC CLIA Waived Antibody Test Kit 20/Box  - Call for volume pricing 404-840-8900

The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only.

The COVID-19 IgG/IgM Rapid Test Device detects anti-SARS-CoV-2 IgG/IgM antibody through visual interpretation of color development. Anti-human IgG and anti-human IgM are used to detect specific antibodies in the human whole blood, serum, or plasma specimen. When specimen is added to the sample well, specific IgM and/or IgG antibodies, if present, will bind to the SARS-CoV-2 antigens conjugated to colored particles on the conjugate pad.

As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgM and/or anti-human IgG antibodies immobilized on the test region(s). Excess colored particle are captured at the internal control region. The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that membrane wicking is working.

Test Kit Includes:

  • 20 Test Cassettes
  • 20 Lancets
  • 20 Alcohol Prep Pads
  • 20 Buffer solutions

FaStep COVID-19 Coronavirus FDA EUA Authorized Antibody Test Kit Documentation

fastep covid igg lgm rapid test device ifu

fda eua assure letter of authorization

fastep covid-19 ifu serology package insert

assure eua poc antibody fact sheet for recipients

Extra Information

Brand:
Assure Tech