Deformability Cytometry For Sepsis Risk Assessment

QUT · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215

Classification

FDA Product Code: QUT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3215
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 3
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown