BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit)

GUDID 00857335005008

The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is 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 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.

Otsuka America Pharmaceutical Inc

Helicobacter pylori urease IVD, kit, chromogenic

• Primary Device ID: 00857335005008
• NIH Device Record Key: 786bc018-36ec-4044-9cd0-e6b8d3d8f562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit)
• Version Model Number: 01
• Company DUNS: 008314390
• Company Name: Otsuka America Pharmaceutical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857335005008 [Primary]
GS1	10857335005029 [Package]; Package: case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100025

FDA Product Code

• OZA: Test, Urea Adult And Pediatric (Breath),

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-16

Devices Manufactured by Otsuka America Pharmaceutical Inc

• 00857335005091 - MyCite Patch: 2021-04-22 2 component patch RW2
• 00857335005053 - MyCite Patch: 2021-01-18 DW5 replacement patch
• 00857335005008 - BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit): 2018-07-06The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is 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 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.
• 00857335005008 - BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit): 2018-07-06 The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated
• 00857335005015 - Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA: 2018-07-06 The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
• 00857335005077 - Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA: 2018-07-06 The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
• 00857335005039 - BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit): 2018-03-29 This is the Metabolic Solutions Kit version of the kit.