Panels › Microbiology › Product code QMI · Class 2
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
Regulation 866.3183
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QMI
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Molecular, Inc. | 1 | 0 |
| Roche Molecular Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 24, 2025 | K241921 | Alinity m BKV Abbott Molecular, Inc. | QMI |
| Sep 2, 2020 | K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. | QMI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.