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

GUDID 00857335005039

This is the Metabolic Solutions Kit version of the kit.

Otsuka America Pharmaceutical Inc

Helicobacter pylori urease IVD, kit, chromogenic

• Primary Device ID: 00857335005039
• NIH Device Record Key: 144744b1-e8ca-476b-b141-2dbe4836e412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)
• Version Model Number: 01M
• 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	00857335005039 [Primary]
GS1	10857335005043 [Package]; Package: case [5 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• 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): 2018-07-06 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): 2018-03-29This is the Metabolic Solutions Kit version of the kit.
• 00857335005039 - BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit): 2018-03-29 This is the Metabolic Solutions Kit version of the kit.