SCX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunoassay For Host Biomarkers Of Sepsis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Medical specialty
- Microbiology
- FDA definition
- A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.
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| Record | Firm | Date |
|---|---|---|
| IVD CAPSULE PSP; abioSCOPE (K240041) | Abionic SA | 2024-09-25 |
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