MZP
- Product code
- MZP
- Device name
- Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3170
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 4 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252484 | 2025-11-03 | Roche Molecular Systems, Inc. | cobas HCV | |
| K252102 | 2025-09-25 | Abbott Molecular, Inc. | Alinity m HCV | |
| K233352 | 2024-07-24 | Hologic, Inc. | Aptima HCV Quant Dx Assay |
Official FDA classification page: MZP
Classification and pathway per current FDA publications. Data from openFDA (CC0).