Product Description
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 signs 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. The Flowflex Plus COVID-19 and Flu A/B Home Test does not differentiate between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens. All negative SARS-CoV-2 results are presumptive.
Clinical Performance:
The Flowflex Plus COVID-19 and Flu A/B Home Test was compared to FDA EUA and 510(k) RT-PCR COVID-19 and Flu A/B assays. The Flowflex Plus COVID-19 and Flu A/B Home Test correctly identified 90.6% of positive specimens and 99.3% of negative specimens for COVID-19, 91.7% of positive specimens and 99.8% of negative specimens for Flu A, and 93.6% of positive specimens and 99.7% of negative specimens for Flu B.
This test procedure overview does not replace the Quick Reference Instructions (QRI). Before you begin the test, it is important to read and follow the detailed instructions in the QRI.
FEATURES & BENEFITS
- 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
- Medical-grade technology used in doctor’s offices
- Compact packaging for “On-The-Go” testing
PRODUCT DETAILS
You may place order by giving us a call
| Catalog Number | Description | Units of Measurements |
| IDL03AR0645 | Flowflex® Plus COVID-19 and Flu A/B Home Test | 1 Test/Kit |
| IDL03AR0745 | Flowflex® Plus COVID-19 and Flu A/B Home Test | 2 Tests/Kit |
| IDL03AR0845 | Flowflex® Plus COVID-19 and Flu A/B Home Test | 5 Tests/Kit |
| IDL03AR0945 | Flowflex® Plus COVID-19 and Flu A/B Home Test | 25 Tests/Kit |
DOCUMENTATION AND VIDEOS
Flowflex Plus COVID-19 and Flu A/B Home Test videos, brochure, package inserts, authorized FDA letter and additional literature provided below:
Jant Pharmacal is an Authorized Distributor for the Flowflex COVID-19 and Flu A/B Home Test.
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.
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
