Home GUDID 00860009877924 kidneyintelX.dkd Test
Primary DI 00860009877924
Brand kidneyintelX.dkd Test
Company Renalytix Ai, Inc.
Model 1
Device description Test Report for the kidneyintelX.dkd test.
Published 2024-09-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name QWZ Prognostic Test For Assessment Of Chronic Kidney Disease Progression
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QWZ Prognostic Test For Assessment Of Chronic Kidney Disease Progression Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860009877924 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860009877924 00860009877924 860009877924 0860009877924
GMDN Terms# Term, Definition table Term Definition Kidney disease progression risk assessment interpretive software IVD An in vitro diagnostic interpretive software program intended to be used in the assessment of risk of progression of chronic kidney disease (CKD). It uses specific algorithms to combine and correlate patient demographics, clinical observations, and the in vitro diagnostic results of the qualitative and/or quantitative detection of one or multiple chronic kidney disease biomarkers in a clinical specimen to establish an individual risk score that may be used to guide patient management to minimise progression to kidney failure and dialysis.
Regulatory Flags# DUNS number 117063935 Device count 1 Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860009877931 kidneyintelX.dkd Single Tube Specimen Collection KIt RENX-3011087 2024-04-16 00860009877917 RenalytixAI Urine Collection Kit RENX3011003 2022-05-06 00860009877900 KidneyIntelX Blood Collection Convenience Kit RENX-3011000 2022-03-25 00196852040506 KidneyIntelX Blood Collection Convenience Kit RENX-3011000 2022-03-25 00196852375677 RenalytixAI Urine Collection Kit RENX3011003 2022-05-06 G229RENX30110031 RenalytixAI Urine Collection Kit RENX3011003 2022-05-06 G229RENX30110001 KidneyIntelX Blood Collection Convenience Kit RENX-3011000 RENX-30110002 2022-03-25 G229RENX301100021 KidneyIntelX Blood Collection Convenience Kit RENX-30110002 RENX-30110002 2022-03-25
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