RenalytixAI Urine Collection Kit

GUDID 00860009877917

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 ID00860009877917
NIH Device Record Key75f43196-36e1-4eb8-9cb5-1f045d969a82
Commercial Distribution StatusIn Commercial Distribution
Brand NameRenalytixAI Urine Collection Kit
Version Model NumberRENX3011003
Company DUNS117063935
Company NameRenalytix Ai, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com
Phone800-203-2725
EmailClientServices@renalytix.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009877917 [Primary]

FDA Product Code

OHZUrine Transport Kit (Excludes Hiv Testing)
OIEUrine Collection Kit (Excludes Hiv Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-04-09
Device Publish Date2022-05-06

On-Brand Devices [RenalytixAI Urine Collection Kit]

G229RENX30110031Collection kit for urine specimen
00196852375677Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory
00860009877917Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory
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