Duns Number:008314390
Device Description: The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualit 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.
Catalog Number
-
Brand Name
BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit)
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P100025,P100025
Product Code
OZA
Product Code Name
Test, Urea Adult And Pediatric (Breath),
Public Device Record Key
786bc018-36ec-4044-9cd0-e6b8d3d8f562
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 16, 2017
Package DI Number
10857335005029
Quantity per Package
5
Contains DI Package
00857335005008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 2 |