Description
FlowFlex FDA EU -Letter
Flowflex-Fact-Sheet Professionals
FlowFlex-flyer
FlowFlex-Frequently Asked Questions
Flowflex-Package-Insert-for-Healthcare-Providers
Flowflex-Package-Insert-for-Individuals
Flowflex-Package-Insert-for-Individuals-in-Spanish
Flowflex-SafetyDataSheet
Flowflex-Technical-Flyer
Unit: 1 Box
Regulatory Status: EUA Approved Only
Test Time: 15 Minutes Minutes
Storage Requirements: Room Temperature
Contents: Swabs (1)individually wrapped sterile foam swab, (1) Test Strip, (1) Pre-filled Buffer Tube, Package Insert
Flowflex COVID-19 Antigen Home Test is 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. For self-testing use. For use under an Emergency Use Authorization (EUA) only.
This test is authorized for non-prescription home use with self collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older. The Flowflex COVID-19 Antigen Home Test does not differentiate between SARSCoV and SARS-CoV-2.
FEATURES & BENEFITS
- Cassette Format
- Detects the nucleocapsid protein antigen from SARS-CoV-2
- Nasal Specimen sample
- Results in 15 minutes
- FDA Emergency Use Authorization (EUA)
- Positive Percent Agreement (PPA): 93% (95% Cl: 81%-99%)
- Negative Percent Agreement (NPA): 100% (95% Cl: 97%-100%)
- Analytical Sensitivity: Limit of Detection (LoD): 2.5 x 103 TCID50/mL
