SCX — Immunoassay For Host Biomarkers Of Sepsis Class II
FDA product code SCX covers "Immunoassay For Host Biomarkers Of Sepsis", a Class II medical device regulated under 21 CFR 866.3215. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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 |