A rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.
This product has not been FDA cleared or approved but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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 IVDs 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.
Video Source: ACON Laboratories, Inc
The Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. It is intended for self-testing use. For use under an Emergency Use Authorization (EUA) only.
This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older.
This test is intended for individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.
Insert the swab ½ to ¾ inches inside your nostril. With children, the maximum depth of insertion into the nostril should be less than ¾ of an inch, and you may need to have a second person hold the child’s head while swabbing.
No, pls do not swab your throat/ear. Only swab your nose to collect samples and follow instructions on the package insert.
Please only use the swab that is provided with the test.
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