Status COVID-19 Antigen Rapid Test Kit for Home Use OTC
The Status™ COVID-19 Antigen Rapid Test for Home Use is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
Product Specifications
| Tests/Box | 1 / 2 / 25 |
| Sample type | Anterior Nasal Swab |
| Time to results | 15 minutes |
| Kit contents | Test Device, Extraction Reagent in Capsules, Sterile Swabs, Package Insert |
| Storage | 35-86°F (2-30°C) |
| Certification | FDA EUA |
More Information
- Status COVID-19 Antigen Rapid Test Kit OTC Brochure.pdf
- Instructions of Use (IFU) Healthcare Provider