This is the Metabolic Solutions Kit version of the kit.

This is the Metabolic Solutions Kit version of the kit.
BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) - 01M

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00857335005039

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

Device Id: 10857335005043

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00857335005039

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: case