The BinaxNOW™ COVID-19 Ag Card* is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven 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.
Test type: Lateral flow immunoassay
Specimen type: Anterior Nasal (Nares) Swabs
Turnaround time: 15-30 minutes
CLIA complexity: Waived
FDA status: Emergency Use Authorization (EUA) granted
Pkg String: 1 EA
Shipping UOM: 1
Description: BinaxNowTM COVID-19 Ag CARD
195-000 - Abbott BinaxNow Antigen Rapid Test 40 tests per box 16 box per case.