FDA.reportPublic FDA data

Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA

Primary DI
00857335005077
Brand
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
Company
Otsuka America Pharmaceutical Inc
Model
2.0
Device description
The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
Published
2017-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OZATest, Urea Adult And Pediatric (Breath),

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZATest, Urea Adult And Pediatric (Breath),Microbiology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100025000BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0Meridian Bioscience, Inc.2012-02-22OZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857335005077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857335005077008573350050778573350050770857335005077

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori urease IVD, kit, chromogenicA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008314390
Device count
1
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857335005114Otsuka Digital Feedback DevicePatchSPC-27312026-05-11
00857335005091MyCite PatchRW22021-04-14
00857335005053MyCite PatchDW52021-01-08
00857335005008BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) 012017-05-16
00857335005015Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA1.12014-09-23
00857335005039BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)01M2017-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860001810325PyloPlus+ Urea Breath Test KitArj Medical, Inc.OZA2025-01-20
00860001810363PyloPlus+ Urea Breath Test AnalyzerArj Medical, Inc.OZA2025-01-20
00860001810370PyloPlus+ Urea Breath Test Pro AnalyzerArj Medical, Inc.OZA2025-01-20
00860001810387PyloPlus+ Urea Breath Test Lab AnalyzerArj Medical, Inc.OZA2025-01-20
00840733101434BreathTek UBT for H. pylori MERIDIAN BIOSCIENCE, INC.OZA2022-02-11
00840733101458Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CAMERIDIAN BIOSCIENCE, INC.OZA2022-02-11
00857335005008BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) Otsuka America Pharmaceutical IncOZA2017-05-16
00857335005039BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)Otsuka America Pharmaceutical IncOZA2017-05-16
00857335005015Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CAOtsuka America Pharmaceutical IncOZA2014-09-23