Flowflex – COVID-19 Antigen Home Tests
In the USA, 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; and,
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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
Categories: COVID-19 Tests, Medical
In the USA, 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; and,
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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
Categories: COVID-19 Tests, Medical
In the USA, 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; and,
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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
Categories: COVID-19 Tests, Medical
Description
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.
With Flowflex, there is no necessary follow-up test, unless new symptoms appear.
The Flowflex COVID-19 Antigen Home Test was compared to an FDA authorized molecular SARS-CoV-2 test. The Flowflex COVID-19 Antigen Home Test correctly identified 93% of positive specimens and 100% of negative specimens.
Features:
Anterior nasal swab specimens
Results in 15 minutes
12 months shelf life
Store between 36° to 86° F/ 2.2° to 30°C
Sample self-collection ages 14 and older
Materials Provided:
Test Cassette(s)
Extraction Buffer Tube(s)
Package Insert
Nasal Swab(s)
External Tube Holder