SCX — Immunoassay For Host Biomarkers Of Sepsis Class II
Classification Details
- Product Code
- SCX
- Device Class
- Class II
- Regulation Number
- 866.3215
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240041 | abionic | IVD CAPSULE PSP; abioSCOPE | September 25, 2024 |