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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW COVID-19 2.0 24T
Product Name: ID NOW COVID-19 2.0 24T
Model/Catalog Number: 192-000
Software Version: N/A
Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle Open, Classified |
QWR | K221925 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW COVID-19 2.0 24T
Product Name: ID NOW COVID-19 2.0 24T
Model/Catalog Number: 192-000
Software Version: N/A
Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle Open, Classified |
QWR | K221925 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.