Status COVID-19 / Flu A&B Test Kit

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• The Test Kits have not been FDA cleared or approved.
• The Test Kits have been authorized by the FDA under an emergency use authorization for use by Authorized Laboratories. "Authorized Laboratories" means laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests.
• These Test Kits are 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.
• Emergency use of these Test Kits is limited to Authorized Laboratories, and 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• The Test Kits have been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens.