OBF

Assay, Genotyping, Hepatitis C Virus

Product code
OBF
Device name
Assay, Genotyping, Hepatitis C Virus
Device class
Class 2
21 CFR
21 CFR 866.3170
Medical specialty
Microbiology
Marketing pathway
510(K)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OBF
Classification and pathway per current FDA publications. Data from openFDA (CC0).