RenalytixAI Urine Collection Kit

GUDID 00196852375677

Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR 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 General specimen collection kit

• Primary Device ID: 00196852375677
• NIH Device Record Key: 75f43196-36e1-4eb8-9cb5-1f045d969a82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RenalytixAI Urine Collection Kit
• Version Model Number: RENX3011003
• 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: true
• 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: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com
• Phone: 800-203-2725
• Email: ClientServices@renalytix.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852375677 [Primary]

FDA Product Code

• OHZ: Urine Transport Kit (Excludes Hiv Testing)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-28
• Device Publish Date: 2022-05-06

On-Brand Devices [RenalytixAI Urine Collection Kit]

• G229RENX30110031: Collection kit for urine specimen
• 00196852375677: Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory
• 00860009877917: Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory