Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA

GUDID 00857335005077

The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.

Otsuka America Pharmaceutical Inc

Helicobacter pylori urease IVD, kit, chromogenic
Primary Device ID00857335005077
NIH Device Record Keyd2a5eb26-05ae-44d1-9c97-87beddaadc26
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
Version Model Number2.0
Company DUNS008314390
Company NameOtsuka America Pharmaceutical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857335005077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZATest, Urea Adult And Pediatric (Breath),

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-19

On-Brand Devices [Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA]

00857335005077The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTe
00857335005015The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTe

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