DEVICE: kidneyintelX.dkd Test (00860009877924)

Device Identifier (DI) Information

kidneyintelX.dkd Test
1
In Commercial Distribution

Renalytix Ai, Inc.
00860009877924
GS1

1
117063935 *Terms of Use
Test Report for the kidneyintelX.dkd test.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
67320 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.
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67319 Multiple chronic kidney disease (CKD) marker IVD, kit, chemiluminescent immunoassay
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple non-genetic markers associated with chronic kidney disease (CKD), [e.g., tumour necrosis factor receptor-1 (TNFR-1), tumour necrosis factor receptor-2 (TNFR-2), kidney injury molecule-1 (KIM-1), blood urea nitrogen (BUN), haemoglobin A1c (HbA1c), albumin and creatinine ration (UACR)] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to determine the risk of kidney function decline in patients with chronic illness e.g., type 2 diabetes and/or CKD. It is not intended to be used for routine kidney function testing.
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FDA Product Code

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Product Code Product Code Name
QWZ Prognostic Test For Assessment Of Chronic Kidney Disease Progression
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN200052 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bcd14861-d103-4cfe-bebb-0d4409ee26f2
October 08, 2024
1
September 30, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

[?]
3175121312
bhuff@renalytix.com
6469466690
aflynn@renalytix.com
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