Description

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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.

Features

• 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 Attachments

Sales Sheet
Quick Instructions Card
Package Insert
Healthcare Provider Fact Sheet
Quick Guide
FlowFlex Plus FAQs

 

NDC Code: 10107-0290-01