CARESTART COVID-19 ANTIGEN TEST RCHM-02071

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  CareStart™ - COVID-19 Antigen RDT - Instructional Video

  For Professional Use Only. If you have any questions, please c...

Intended Use: The CareStartCOVID-19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use 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. This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; ï‚· This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and ï‚· The emergency use of this product 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.