OBF — Assay, Genotyping, Hepatitis C Virus Class II
FDA product code OBF covers "Assay, Genotyping, Hepatitis C Virus", a Class II medical device regulated under 21 CFR 866.3170. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- OBF
- Device Class
- Class II
- Regulation Number
- 866.3170
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes