← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MZP — Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3170
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K252484Roche Molecular Systems, Inc. · 510k2025-11-03
K252102Abbott Molecular, Inc. · 510k2025-09-25

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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