FaStep : IgG/IgM Antibody Rapid Test Kit (FDA/EUA)
Regular price
$325.00
Sale price
$325.00
Regular price
$350.00
Unit price
Sale
- Authorized by FDA under an EUA
- Results in 15 minutes
- High accuracy
- Easy to use
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FaStep COVID-19 IgG/IgM Antibody Rapid Test Device by Azure Biotech 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. FaStep is authorized for use with fingerstick whole blood specimen at the point-of-care. FaStep has been validated by the FDA and found to have a 100% Sensitivity for IgM (30/30) and 98.8% Specificity for IgM (79/80). IgG Sensitivity was 90% (27/30) and Specificity was 100% (80/80).
- This test has been authorized by the FDA under a EUA for use by authorized laboratories. It is a point-of-care test for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
- 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 the 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.
- Read the complete Quick Reference Instructions before performing the test.
- There should be a blue line in the control region (next to “C”) before testing, discard the device if there is no blue line.
- Due to the risk of false-positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.
- (20) IgG/IgM Rapid Antibody Tests Cassettes
- (20) Sterile Fingerstick Lancets
- (20) Sterile Alcohol Pads
- (20) Droppers for Blood Collection
- (20) Vials with Buffer
Pro-Tip
Innovative Thinking and Reliable Technology
Azure Biotech, Inc.is a high-tech biotechnology company that specializes in research & development, production and sales of diagnostic reagents, POCT analyzers, and biological materials. We utilize advanced colloidal gold diagnostic reagents production lines to produce hundreds of millions of devices each year. Currently, our R&D team has over 100 employees, along with extensive collaborations with renowned domestic and foreign research institutions.
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About Azure Biotech
Cutting-edge science, innovative thinking and reliable technology.
Azure Biotech, Inc.is a high-tech biotechnology company that specializes in research & development, production and sales of diagnostic reagents, POCT analyzers, and biological materials. We utilize advanced colloidal gold diagnostic reagents production lines to produce hundreds of millions of devices each year.
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