Pure Global AI
FDA product code OBF

Assay, Genotyping, Hepatitis C Virus

MicrobiologyClass 221 CFR 866.3170
Verified
US regulatory classifications
US Product Code (FDA)
OBF
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3170
View CFR Regulation
Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes

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01Assay02Genotyping03Hepatitis C04HCV genotyping05Viral assay06Infectious disease07Diagnostic assay08Molecular test09Genotype test10HCV test
About this record

Assay, Genotyping, Hepatitis C Virus is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.