QPS — Immunoassay For Host Biomarkers Of Infection Class II
FDA product code QPS covers "Immunoassay For Host Biomarkers Of Infection", a Class II medical device regulated under 21 CFR 866.3215. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QPS
- Device Class
- Class II
- Regulation Number
- 866.3215
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.