RenalytixAI Urine Collection Kit

GUDID G229RENX30110031

General specimen collection kit

Primary Device ID	G229RENX30110031
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	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
HIBCC	G229RENX30110031 [Primary]

OHZ	Urine Transport Kit (Excludes Hiv Testing)

Steralize Prior To Use	false
Device Is Sterile	false

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