FDA Product Code MZP: Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
FDA product code MZP covers hybridization and nucleic acid amplification assays used for pathogen identification from clinical specimens.
These molecular tests use probe hybridization or amplification techniques to detect specific nucleic acid sequences from bacteria, fungi, viruses, or parasites, providing pathogen identification from culture isolates or directly from clinical specimens.
MZP devices are Class II medical devices, regulated under 21 CFR 866.3170 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Molecular Systems, Inc., Hologic, Inc. and Abbott Molecular, Inc..
4
Total
4
Cleared
171d
Avg days
2022
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg
86d
recently vs 256d historically
FDA 510(k) Cleared Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus Devices (Product Code MZP)
4 devices
Cleared
Nov 03, 2025
cobas HCV
Roche Molecular Systems, Inc.
Microbiology
88d
Cleared
Sep 25, 2025
Alinity m HCV
Abbott Molecular, Inc.
Microbiology
84d
Cleared
Jul 24, 2024
Aptima HCV Quant Dx Assay
Hologic, Inc.
Microbiology
299d
Cleared
Nov 04, 2022
cobas HCV
Roche Molecular Systems, Inc.
Microbiology
213d
About Product Code MZP - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code MZP since 2022, with 4 receiving FDA clearance (average review time: 171 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - MZP Product Code
Recent submissions under MZP have taken an average of 86 days to reach a decision - down from 256 days historically, suggesting improved FDA processing for this classification.
MZP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →