Panels › Microbiology › Product code MZP · Class 2
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Regulation 866.3170
1510(k)s in 12 months (4 all time)
0recalls in 12 months (11 all time)
0recalls that name a 510(k)
Top companies in MZP
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Molecular, Inc. | 1 | 6 |
| Roche Molecular Systems, Inc. | 2 | 5 |
| Hologic, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 3, 2025 | K252484 | cobas HCV Roche Molecular Systems, Inc. | MZP |
| Sep 25, 2025 | K252102 | Alinity m HCV Abbott Molecular, Inc. | MZP |
| Jul 24, 2024 | K233352 | Aptima HCV Quant Dx Assay Hologic, Inc. | MZP |
| Nov 4, 2022 | K221007 | cobas HCV Roche Molecular Systems, Inc. | MZP |
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