BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit)
Basic Information
- Brand Name
- BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit)
- Primary DI
- 00857335005008
- Version / Model
- 01
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 786bc018-36ec-4044-9cd0-e6b8d3d8f562
Device Description
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.
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 | 00857335005008 | GS1 | ||||
| Package | 10857335005029 | GS1 | case | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100025 | 000 |