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..
FDA 510(k) Cleared Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus Devices (Product Code MZP)
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 increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MZP have taken an average of 157 days to reach a decision - down from 213 days historically, suggesting improved FDA processing for this classification.
MZP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →