Panels › Microbiology › Product code PAB · Class 2
Cytomegalovirus (Cmv) Dna Quantitative Assay
Regulation 866.3180
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 PAB
| Company | 510(k)s | Recalls |
|---|---|---|
| Hologic, Inc. | 1 | 1 |
| Abbott Molecular, Inc. | 1 | 0 |
| Roche Molecular Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 3, 2025 | K252481 | cobas CMV Roche Molecular Systems, Inc. | PAB |
| Jul 1, 2025 | K243485 | Alinity m CMV Abbott Molecular, Inc. | PAB |
| Jan 17, 2025 | K243935 | Aptima CMV Quant Assay Hologic, Inc. | PAB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.