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K Number
K093960
Device Name
ST AIA-PACK CYSTATIN C, MODEL 025217
Manufacturer
Tosoh BioScience, Inc.
Date Cleared
2010-09-14

(265 days)

Product Code
NDY
Regulation Number
862.1225
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.