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


Product Overview

The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA - 1.1


Device Description

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.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: OZA

Device Name: Test, Urea Adult And Pediatric (Breath),

Device Class: 3

Physical State: Human Breath

Definition: Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy.

Submission Type ID: 2

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: System utilizes an Infrared Spectrophotometer

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Stomach, esophagogastroduodenoscopy

Regulation Number: 866.3110

Third Party Flag: N

Medical Specialty: MI


Device Identifiers

Device Id: 00857335005015

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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