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FDA TGA Nasopharyngeal Antigen Test Flowflex Nasal Specimen

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FDA TGA Nasopharyngeal Antigen Test Flowflex Nasal Specimen

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MOQ :	1000 Test

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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

FDA TGA Nasopharyngeal Antigen Test Flowflex Nasal Specimen

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