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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2026 | K253453 | Metrix COVID Test; Metrix COVID Test Pro Aptitude Medical Systems, Inc. | QWB |
| Nov 28, 2023 | K232643 | Cue COVID-19 Molecular Test Cue Health, Inc. | QWB |
| Jun 6, 2023 | DEN220028 | Cue COVID-19 Molecular Test Cue Health, Inc. | QWB |
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