Product code MZP— Microbiology

cobas HCV

Classification name: Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Device class: Class 2
Regulation: 21 CFR 866.3170
Advisory panel: Microbiology
Total cleared: 4
First cleared: 2022-11-04
Most recent: 2025-11-03

Market context for product code MZP

FDA has cleared 4 devices under product code MZP between 2022 and 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20252 clearances
20241 clearance
20221 clearance

Top applicants under product code MZP

Roche Molecular Systems, Inc.2 clearances
Hologic, Inc.1 clearance
Abbott Molecular, Inc.1 clearance

Recent clearances under product code MZP

K252484 — cobas HCVRoche Molecular Systems, Inc.·2025-11-03
K252102 — Alinity m HCVAbbott Molecular, Inc.·2025-09-25
K233352 — Aptima HCV Quant Dx AssayHologic, Inc.·2024-07-24
K221007 — cobas HCVRoche Molecular Systems, Inc.·2022-11-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.