Panels › Microbiology › Product code QWR · Class 2
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Regulation 866.3982
0510(k)s in 12 months (3 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in QWR
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Diagnostics Scarborough, Inc. | 1 | 2 |
| Roche Molecular Systems, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2025 | K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test Roche Molecular Systems, Inc. | QWR |
| Dec 4, 2023 | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | QWR |
| Aug 10, 2023 | K221925 | ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, Inc. | QWR |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.