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MZO — Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Class II

FDA Device Classification

Classification Details

Product Code
MZO
Device Class
Class II
Regulation Number
866.3169
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252424abbott laboratoriesAnti-HCV NextApril 28, 2026
K221693roche diagnosticsElecsys Anti-HCV II (08837031190)January 4, 2023