FDA product code OBF: Assay, Genotyping, Hepatitis C Virus
OBF is the FDA product code for assay, genotyping, hepatitis c virus. It is a Class II device, regulated under 21 CFR 866.3170 and reviewed by the Microbiology panel. Devices under OBF reach the market by 510(k); FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Definition
In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes
Classification
| Field | Value |
|---|---|
| Device name | Assay, Genotyping, Hepatitis C Virus |
| Device class | Class II |
| Regulation | 21 CFR 866.3170 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for OBF devices
openFDA lists no recalls for product code OBF.
Frequently asked questions
What is FDA product code OBF?
OBF is the FDA product code for assay, genotyping, hepatitis c virus. It is a Class II device, regulated under 21 CFR 866.3170 and reviewed by the Microbiology panel.
What device class is OBF?
Class II, regulation 21 CFR 866.3170. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OBF
- Run a recall and safety report across every OBF manufacturer
- Watch product code OBF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.