MZP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3170
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2010: 11 · 2011: 44 · 2012: 26 · 2013: 36 · 2014: 13 · 2016: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date |
|---|---|---|
| cobas HCV (K252484) | Roche Molecular Systems, Inc. | 2025-11-03 |
| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
| Aptima HCV Quant Dx Assay (K233352) | Hologic, Inc. | 2024-07-24 |
| cobas HCV (K221007) | Roche Molecular Systems, Inc. | 2022-11-04 |
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Every clearance here is in the API, with alerts when new ones post.