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. and Hologic, Inc..
List of Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus devices (product code MZP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →