Status™ COVID-19/Flu A&B Combo Rapid Immunoassay, EUA Approved, 25/Box

• Detects SARS-CoV-2, Influenza A, and Influenza B simultaneously (~15-minute results)
• Sample types: Anterior nasal or nasopharyngeal swab
• Performance: COVID-19 (~93-94 % sensitivity, 100 % specificity), Flu A (~91 % sensitivity), Flu B (~87-88 % sensitivity)—as reported by the manufacturer
• Authorized under FDA EUA; CLIA-waived; suitable for point-of-care use
• The Status™ COVID-19/ Flu A&B is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests.
• The Status™ COVID-19/ Flu A&B 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.

Product Documentation

Status COVID-19 Flu 24 Month Expiration Letter

Status Flu A & B Annual Reactivity Testing Results Table

Status COVID-19 Flu Quick Reference Instructions / Procedure Card

Status LifeSign COVID-19 Flu Sell Sheet

Status COVID-19 Flu Princeton BioMeditech Patient Fact Sheet

Status COVID-19 Flu Princeton Princeton BioMeditech Healthcare Providers Fact Sheet

For in vitro diagnostic use under FDA Emergency Use Authorization only. Use per Instructions for Use. Not FDA-cleared beyond EUA scope.

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