← FDA Medical Device Classifications
Antibodies, Outer-Membrane Proteins
OKM · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5785
Classification
- FDA Product Code
OKM- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.5785
- Review panel
- IM
- Medical specialty
- Immunology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown