Deformability Cytometry For Sepsis Risk Assessment
Medical specialty
Microbiology
Device class
2
Regulation number
866.3215
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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