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2765-31185
Flowflex® COVID-19 Antigen Home Test
Manufacturer:
JANT PHARMACAL CORP.
Manufacturer:
JANT PHARMACAL CORP.
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.
Features:
- 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
CLIA Complexity: Waived
For further information regarding CLIA, see below:
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