Home GUDID 00857335005039 BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)
Primary DI 00857335005039
Brand BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)
Company Otsuka America Pharmaceutical Inc
Model 01M
Device description This is the Metabolic Solutions Kit version of the kit.
Published 2017-05-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name OZA Test, Urea Adult And Pediatric (Breath),
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OZA Test, Urea Adult And Pediatric (Breath), Microbiology 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10857335005043 Package GS1 5 In Commercial Distribution 00857335005039 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 10857335005043 10857335005043 00857335005039 00857335005039 857335005039 0857335005039
GMDN Terms# Term, Definition table Term Definition Helicobacter pylori urease IVD, kit, chromogenic A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen, using a chromogenic test method.
Regulatory Flags# DUNS number 008314390 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00857335005114 Otsuka Digital Feedback Device Patch SPC-2731 2026-05-11 00857335005091 MyCite Patch RW2 2021-04-14 00857335005053 MyCite Patch DW5 2021-01-08 00857335005008 BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) 01 2017-05-16 00857335005015 Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA 1.1 2014-09-23 00857335005077 Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA 2.0 2017-04-19
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860001810325 PyloPlus+ Urea Breath Test Kit Arj Medical, Inc. OZA 2025-01-20 00860001810363 PyloPlus+ Urea Breath Test Analyzer Arj Medical, Inc. OZA 2025-01-20 00860001810370 PyloPlus+ Urea Breath Test Pro Analyzer Arj Medical, Inc. OZA 2025-01-20 00860001810387 PyloPlus+ Urea Breath Test Lab Analyzer Arj Medical, Inc. OZA 2025-01-20 00840733101434 BreathTek UBT for H. pylori MERIDIAN BIOSCIENCE, INC. OZA 2022-02-11 00840733101458 Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA MERIDIAN BIOSCIENCE, INC. OZA 2022-02-11 00857335005008 BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) Otsuka America Pharmaceutical Inc OZA 2017-05-16 00857335005077 Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA Otsuka America Pharmaceutical Inc OZA 2017-04-19 00857335005015 Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA Otsuka America Pharmaceutical Inc OZA 2014-09-23