Flowflex COVID-19 Antigen Home Test Kit, 25 tests per Kit. This product is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2, not for any other viruses. For use with direct anterior nasal and nasopharyngeal swab specimens, non-invasive test procedures.
Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.
includes the following; 25 Sterile Nasal Swabs, 25 Test Cassettes, 25 Extraction Buffer Tubes, 1 Tube Holder, 1 Package insert. Authorized by the FDA for use under an EUA only, FlowFlex antigen rapid tests provide precise, reliable results in 15 minutes. Intended to be used twice within two to thee days, with 24 to 48 hours between each test.
For use with direct anterior nasal and nasopharyngeal swab specimens, non-invasive test procedures.
- Accuracy: Nasal Swab: 98.8% (95% CI: 97.6%-99.5%) 95% Confidence Intervals
- Saliva: 97.1% (95% CI: 94.6%-98.5%) 95% Confidence Intervals
- Variant-ready solution.
- Rapid results within 15 minutes
THIS PRODUCT USUALLY SHIPS WITHIN 1 BUSINESS DAY. THIS PRODUCT IS NOT RETURNABLE. ALL SALES ARE FINAL. BULK FAMILY PACK OF 25 TESTS, NOT PACKAGED FOR RESELL.
- FlowFlex COVID-19 Antigen Rapid Test, 25 tests per pack
- Only need to use 1 test per person (no serial testing required)
- Contents: 25 Test Kit includes the following; 25 Sterile Nasal Swabs, 25 Test Cassettes, 25 Extraction Buffer Tubes, 1 Tube Holder, 1 Package insert
- Authorized by the FDA for use under an EUA only
- Acon Laboratories, Inc.
A summary of the performance information FDA relied upon is included in the “Flowflex COVID-19 Antigen Home Test Package Insert” Healthcare Provider instructions for use identified below. Criteria for Issuance of Authorization I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that:
- The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
- Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product;
- There is no adequate, approved, and available alternative to the emergency use of your product.
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