kidneyintelX.dkd Test

Basic Information

• Brand Name: kidneyintelX.dkd Test
• Primary DI: 00860009877924
• Version / Model: 1
• Company Name: Renalytix Ai, Inc.
• Labeler DUNS: 117063935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-30
• Public Version: 1
• Public Version Date: 2024-10-08
• Public Version Status: New
• Public Device Record Key: bcd14861-d103-4cfe-bebb-0d4409ee26f2

Device Description

Test Report for the kidneyintelX.dkd test.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QWZ	Prognostic Test For Assessment Of Chronic Kidney Disease Progression	Clinical Chemistry	862.1223	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009877924	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN200052	000