Premier Biotech #CV-AZ19W Rapid Test Kit FaStep® Antibody Test COVID-19 IgG / IgM Human Whole Blood / Serum / Plasma Sample 20 Tests RAPID TEST, COVID-19 IGG/IGM CASSETTE (20/CS) 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 Manufacturer # CV-AZ19W Brand FaStep® Manufacturer Premier Biotech Country of Origin Unknown 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 Acceptable Dating: we will ship >= 30 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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