← FDA Medical Device Classifications
C. Difficile Toxin Gene Amplification Assay
OZN · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3130
Classification
- FDA Product Code
OZN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.3130
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Market data
- Cleared 510(k) submissions
- 17
- Registered establishments
- 13
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown