Panels › Microbiology › Product code QWB · Class 2
Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Regulation 866.3984
1510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in QWB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cue Health, Inc. | 2 | 1 |
| Aptitude Medical Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2024 | CUE HEALTH INC Cue Health COVID-19 Test Cartridge REF 2900005
Cue COVID-19 Test
Cue COVID-19 Test for Home and Over The Counter (OTC) Open, Classified |
QWB | None listed |
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