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

FDA Device Classification

FDA product code MZP covers "Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus", a Class II medical device regulated under 21 CFR 866.3170. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MZP
Device Class
Class II
Regulation Number
866.3170
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252484roche molecular systemscobas HCVNovember 3, 2025
K252102abbott molecularAlinity m HCVSeptember 25, 2025
K233352hologicAptima HCV Quant Dx AssayJuly 24, 2024
K221007roche molecular systemscobas HCVNovember 4, 2022