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

• 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