← FDA Medical Device Classifications
Assay, Genotyping, Hepatitis C Virus
OBF · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3170
Classification
- FDA Product Code
OBF- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.3170
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown