kidneyintelX.dkd Single Tube Specimen Collection KIt

GUDID 00860009877931

Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing

Renalytix Ai, Inc.

General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit

• Primary Device ID: 00860009877931
• NIH Device Record Key: f7aea458-95c9-49fb-ada3-03264cdde594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: kidneyintelX.dkd Single Tube Specimen Collection KIt
• Version Model Number: RENX-3011087
• Company DUNS: 117063935
• Company Name: Renalytix Ai, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009877931 [Primary]

FDA Product Code

• PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

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: 2024-04-24
• Device Publish Date: 2024-04-16

Devices Manufactured by Renalytix Ai, Inc.

• 00860009877931 - kidneyintelX.dkd Single Tube Specimen Collection KIt: 2024-04-24Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing
• 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
• G229RENX301100021 - KidneyIntelX Blood Collection Convenience Kit: 2022-04-04 Whole blood collection convenience kit for KidneyIntelX