Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
The Hybridization and/or Nucleic Acid Amplification Assay for Detection of Hepatitis C Virus RNA is an in vitro diagnostic device that uses molecular techniques such as PCR or hybridization to detect and/or quantify HCV RNA in patient specimens, enabling confirmation of active HCV infection and monitoring of treatment response. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.3170 (Microbiology specialty).
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Basic Information
- Product Code
- MZP
- Device Class
- FDA class 2
- Regulation Number
- 866.3170
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252484 | cobas HCV | Nov 03, 2025 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K252102 | Alinity m HCV | Sep 25, 2025 | Substantially Equivalent | Abbott Molecular, Inc. |
| K233352 | Aptima HCV Quant Dx Assay | Jul 24, 2024 | Substantially Equivalent | Hologic, Inc. |
| K221007 | cobas HCV | Nov 04, 2022 | Substantially Equivalent | Roche Molecular Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.