kidneyintelX.dkd Test

GUDID 00860009877924

Test Report for the kidneyintelX.dkd test.

Renalytix Ai, Inc.

Kidney disease progression risk assessment interpretive software IVD

• Primary Device ID: 00860009877924
• NIH Device Record Key: bcd14861-d103-4cfe-bebb-0d4409ee26f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: kidneyintelX.dkd Test
• Version Model Number: 1
• Company DUNS: 117063935
• Company Name: Renalytix Ai, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com
• Phone: 3175121312
• Email: bhuff@renalytix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009877924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200052

FDA Product Code

• QWZ: Prognostic Test For Assessment Of Chronic Kidney Disease Progression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-08
• Device Publish Date: 2024-09-30

Devices Manufactured by Renalytix Ai, Inc.

• 00860009877924 - kidneyintelX.dkd Test: 2024-10-08Test Report for the kidneyintelX.dkd test.
• 00860009877924 - kidneyintelX.dkd Test: 2024-10-08 Test Report for the kidneyintelX.dkd test.
• 00860009877931 - kidneyintelX.dkd Single Tube Specimen Collection KIt: 2024-04-24 Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintel
• 00860009877900 - KidneyIntelX Blood Collection Convenience Kit: 2024-04-09 Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX tes
• 00860009877917 - RenalytixAI Urine Collection Kit: 2024-04-09 Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing
• 00196852040506 - KidneyIntelX Blood Collection Convenience Kit: 2023-02-28 Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX tes
• 00196852375677 - RenalytixAI Urine Collection Kit: 2023-02-28 Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing
• G229RENX30110031 - RenalytixAI Urine Collection Kit: 2022-05-16 Collection kit for urine specimen
• G229RENX30110001 - KidneyIntelX Blood Collection Convenience Kit: 2022-05-11 Whole blood collection convenience kit for KidneyIntelX