Description
Unit: 12 Kit (24 Tests)
Regulatory Status: CLIA Exempt
Contents: (24) Test devices, (24) Nasal Swabs, (24) Reagent bottles, (12) Package inserts
Storage Requirements: 35° – 86° F
Processing Time: 15 minutes
BinaxNow-Covid-19 Product Sheet
BinaxNOW-COVID19-Antigen-Self-Test-Product-Insert
- Results in 15 minutes
- For ages 2+
- Same technology doctors use to test for COVID-19
- Detects multiple COVID-19 variants*
- FSA/HSA eligible
BinaxNOW COVID-19 Ag Card is a rapid lateral flow immunoassay for the qualitative detection and diagnosis of SARS-CoV-2 directly from nasal swabs, without viral transport media. The BinaxNOW COVID-19 Ag Card kit contains all components required to carry out an assay for SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven days of symptom onset. This test is also authorized for non-prescription home use with adult collected anterior nasal (nares) swab samples from individuals aged two years or older with symptoms of COVID-19 within the first seven days of symptom onset.
*The BinaxNOW™ COVID-19 Antigen Self Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens, 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
