iHealth COVID-19 Rapid Antigen – Over the Counter
iHealth COVID-19 Antigen HOME KIT is intended for the qualitative detection of SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
- FDA EUA: Yes.
- Application: Over the Counter (OTC)
- Results: 10 minutes
- Type: Lower Nasal
- PPA: 94.3%
- NPA: 99.5%
- Tests per Kit: 2, 5 or 40 packs
- Availability: Immediate, OTG and Production
FDA EUA
YES
TEST TYPE
Rapid Antigen
TEST APPLICATION
Lower nasal, OVER THE COUNTER
TEST TIME
10 minutes
