Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Deformability Cytometry For Sepsis Risk Assessment

FDA product code QUT · 3 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3215
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-12-20 – 2025-11-19

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

↑