← FDA Medical Device Classifications
Immunoassay For Host Biomarkers Of Sepsis
SCX · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215
Classification
- FDA Product Code
SCX- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.3215
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown