510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QUTClass II

Deformability Cytometry For Sepsis Risk Assessment

21 CFR 866.3215 / Microbiology
FDA source (opens on fda.gov)

QUT is the FDA product code for Deformability Cytometry For Sepsis Risk Assessment, a class II device type, regulated under 21 CFR 866.3215. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QUT
Device name
Deformability Cytometry For Sepsis Risk Assessment
FDA 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
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QUT

By decision year
3 clearances under product code QUT with a decision year between 2022 and 2025, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QUT by decision year
YearClearances
20221
20252

Applicants with the most clearances

Product code QUT
Applicants holding the most 510(k) clearances under product code QUT
ApplicantClearances
Cytovale, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code