Home / Clinical Laboratory / Test Kits / Rapid Test Kit / Rapid Test Kit FaStep® Antibody Test COVID-19 IgG / IgM Human Whole Blood / Serum / Plasma Sample 20 TestsCV-AZ19W
Picture of Rapid Test Kit FaStep® Antibody Test COVID-19 IgG / IgM Human Whole Blood / Serum / Plasma Sample 20 TestsCV-AZ19W

Rapid Test Kit FaStep® Antibody Test COVID-19 IgG / IgM Human Whole Blood / Serum / Plasma Sample 20 TestsCV-AZ19W

Rapid-Test-Kit-FaStep®-Antibody-Test-COVID-19-IgG--IgM-Human-Whole-Blood--Serum--Plasma-Sample-20-TestsCV-AZ19W

SKU #

#1177855

MPN #

CV-AZ19W

Brand

Premier Biotech

Stock

In Stock

Quantity

100

Features

RAPID TEST, COVID-19 IGG/IGM CASSETTE (20/CS)

$137.08 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1177855
Manufacturer # CV-AZ19W
Brand FaStep®
Manufacturer Premier Biotech
Application Rapid Test Kit
Contents (20) Test Cassettes, Disposable Pipettes, Buffer, Package Insert, Sterile Safety Lancet, Alcohol Prep Pad
Number of Tests 20 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Reading Type Visual Read
Sample Type Human Whole Blood / Serum / Plasma Sample
Storage Requirements USP Controlled Room Temperature
Test Format Cassette Format
Test Method Lateral Flow Method
Test Name COVID-19 IgG / IgM
Test Type Antibody Test
Time To Results 15 Minute Results
UNSPSC Code 41116126
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  • The Assure COVID-19 IgG/IgM Rapid Test Device is for use under FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests; this test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
  • The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection - at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • False positive results for Assure COVID-19 IgG/IgM Rapid Test Device may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay
  • 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