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Deformability Cytometry For Sepsis Risk Assessment

Deformability Cytometry For Sepsis Risk Assessment is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Deformability Cytometry For Sepsis Risk Assessment
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QUT

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Class 2

21 CFR 866.3215

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Microbiology

Device Characteristics

No

No

No

Not Eligible

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