QWB
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3984
- Medical specialty
- Microbiology
- FDA definition
- An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Metrix COVID Test; Metrix COVID Test Pro (K253453) | Aptitude Medical Systems, Inc. | 2026-08-07 |
| Cue COVID-19 Molecular Test (K232643) | Cue Health, Inc. | 2023-11-28 |
| Cue COVID-19 Molecular Test (DEN220028) | Cue Health, Inc. | 2023-06-06 |
Track QWB automatically
Every clearance here is in the API, with alerts when new ones post.