Duns Number:092815364
Device Description: The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualita 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 is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration 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 the heath care professional, as ordered by a licensed health care practitioner.
Catalog Number
8209
Brand Name
BreathTek UBT for H. pylori
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
Yes
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
7bbfd703-77b5-41e9-a11b-fe98c3909789
Public Version Date
February 21, 2022
Public Version Number
1
DI Record Publish Date
February 11, 2022
Package DI Number
00840733101441
Quantity per Package
5
Contains DI Package
00840733101434
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kits / Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |