QUT — Deformability Cytometry For Sepsis Risk Assessment Class II
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