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SCXClass II

Immunoassay For Host Biomarkers Of Sepsis

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

SCX is the FDA product code for Immunoassay For Host Biomarkers Of Sepsis, a class II device type, regulated under 21 CFR 866.3215. FDA's definition for this code reads: "A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SCX
Device name
Immunoassay For Host Biomarkers Of Sepsis
FDA definition
A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.
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
1
Ingested recalls
0

Clearances, product code SCX

By decision year
1 clearance under product code SCX with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SCX by decision year
YearClearances
20241

Applicants with the most clearances

Product code SCX
Applicants holding the most 510(k) clearances under product code SCX
ApplicantClearances
Abionic SA1

Companies listing this code with FDA

Companies whose registered establishments list this code