FDA TGA Nasopharyngeal Antigen Test Flowflex Nasal Specimen
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.
Materials Provided:
•Test Cassette(s)
•Package Insert
•Extraction Buffer Tube(s)
•Nasal Swab(s)
• 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, 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 Clear 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.
• For more information on EUAs please visit: https://www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
• For the most up to date information on Clear 19, please visit: www.cdc.gov/Clear 19
• For detailed instructions, please visit: www.aconlabs.com
