QUT — Deformability Cytometry For Sepsis Risk Assessment Class II
FDA product code QUT covers "Deformability Cytometry For Sepsis Risk Assessment", a Class II medical device regulated under 21 CFR 866.3215. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QUT
- Device Class
- Class II
- Regulation Number
- 866.3215
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A semi-quantitative assay that measures cellular deformability and other physical properties of leukocytes in whole blood samples to aid the early detection of sepsis