MZP — Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Class II
FDA Device Classification
Classification Details
- Product Code
- MZP
- Device Class
- Class II
- Regulation Number
- 866.3170
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252484 | roche molecular systems | cobas HCV | November 3, 2025 |
| K252102 | abbott molecular | Alinity m HCV | September 25, 2025 |
| K233352 | hologic | Aptima HCV Quant Dx Assay | July 24, 2024 |
| K221007 | roche molecular systems | cobas HCV | November 4, 2022 |