Product code SCX
- Device name
- Immunoassay For Host Biomarkers Of Sepsis
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3215
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.
- Source
- FDA openFDA device classification dataset