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

Basic Information

• Brand Name: BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)
• Primary DI: 00857335005039
• Version / Model: 01M
• Company Name: Otsuka America Pharmaceutical Inc
• Labeler DUNS: 008314390
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 144744b1-e8ca-476b-b141-2dbe4836e412

Device Description

This is the Metabolic Solutions Kit version of the kit.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OZA	Test, Urea Adult And Pediatric (Breath),	Microbiology	866.3110	3

GMDN Terms

Code	Name	Definition	Implantable	Status
52787	Helicobacter pylori urease IVD, kit, chromogenic	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857335005039	GS1
Package	10857335005043	GS1	case	5	In Commercial Distribution