Home GUDID 00196852375677 RenalytixAI Urine Collection Kit
Primary DI 00196852375677
Brand RenalytixAI Urine Collection Kit
Company Renalytix Ai, Inc.
Model RENX3011003
Device description Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing
Published 2022-05-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OHZ Urine Transport Kit (Excludes Hiv Testing)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OHZ Urine Transport Kit (Excludes Hiv Testing) Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00196852375677 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00196852375677 00196852375677 196852375677 0196852375677
GMDN Terms# Term, Definition table Term Definition General specimen collection kit A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 117063935 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860009877924 kidneyintelX.dkd Test 1 2024-09-30 00860009877931 kidneyintelX.dkd Single Tube Specimen Collection KIt RENX-3011087 2024-04-16 00860009877917 RenalytixAI Urine Collection Kit RENX3011003 2022-05-06 00860009877900 KidneyIntelX Blood Collection Convenience Kit RENX-3011000 2022-03-25 00196852040506 KidneyIntelX Blood Collection Convenience Kit RENX-3011000 2022-03-25 G229RENX30110031 RenalytixAI Urine Collection Kit RENX3011003 2022-05-06 G229RENX30110001 KidneyIntelX Blood Collection Convenience Kit RENX-3011000 RENX-30110002 2022-03-25 G229RENX301100021 KidneyIntelX Blood Collection Convenience Kit RENX-30110002 RENX-30110002 2022-03-25
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860010959220 US Biotek Laboratories U.S. Biotek Laboratories LLC OHZ 2023-09-15 00860009877917 RenalytixAI Urine Collection Kit Renalytix Ai, Inc. OHZ 2022-05-06 G229RENX30110031 RenalytixAI Urine Collection Kit Renalytix Ai, Inc. OHZ 2022-05-06
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