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Flowflex® PLUS COVID-19 & Flu A/B Home Test

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ACON Laboratories, Inc. is the only legal manufacturer of the FDA 510(k) Flowflex COVID-19 Antigen Home Test. 🔗 More info

The Flowflex® PLUS COVID-19 and Flu A/B Home Test is all you need to determine your family’s COVID-19/Flu status.

The Flowflex Plus COVID-19 and Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older.

This test is only authorized for individuals with sign and symptoms of respiratory infection consistent with COVID-19 within the first six (6) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
  • Exp. Date: 11-18-25
  • 1 test per box
  • 3-in-1 test for COVID-19, Flu A, and Flu B
  • Easy-to-use nasal swab test
  • Can be used to test children as young as 2 years old
  • Results in 15 minutes
  • No need to send off to a lab to obtain results
Read the instructions fully and carefully before performing the test. Failure to follow the instructions may result in inaccurate test results. This test may only be used in symptomatic individuals.

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, 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 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.

Serial testing should be performed in symptomatic individuals with SARS-CoV-2 negative results at least twice over three days (with 48 hours between tests). You may need to purchase additional tests to perform this serial (repeat) testing.

Consistent with serial testing recommendations for SARS-CoV-2, for multi-analyte tests, symptomatic individuals who test positive for influenza A or B on the initial test but test negative for SARS-CoV-2 should be tested again in 48 hours to evaluate for co-infection with SARS-CoV-2 infection. This test is read visually. Individuals with impaired vision or color-impaired vision should seek help in interpretation of their test results. Do not use the test after the expiration date shown on the test cassette pouch or if the test kit contents are damaged or opened.

Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
Do not use on anyone under 2 years of age.
The swab specimen should be processed and tested immediately after collection.
Leave the test cassette sealed in its pouch until just before use.
Once opened, the test cassette should be used within 60 minutes to prevent false test results.

About Flowflex
Leading the way in global diagnostics.
ACON Laboratories makes Point-of-care medical diagnostics affordable to people all around the world. We provide rapid diagnostics and healthcare products based on a philosophy of high quality, affordability and superior flexibility.