OZAClass III
Test, Urea Adult And Pediatric (breath),
Microbiology · 21 CFR 866.3110
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. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy.
MDR events6All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances0All time
Recent MDR events
6 adverse event reports on file
- BREATHTEK UBTJan 13, 2023InjuryMeridian Bioscience Inc.1524213-2023-00001
- BREATHTEK UBTMar 28, 2022InjuryMeridian Bioscience Inc.1524213-2022-00003
- BREATHTEK UBTFeb 25, 2022MalfunctionMeridian Bioscience Inc.1524213-2022-00002
- UREA WITH CITRIC ACID BREAST TESTJul 19, 2021InjuryUnkMW5102628
- BREATH TEK FOR H. PYLORIJan 8, 2019InjuryOtsuka America Pharmaceutical Inc.MW5082969
- BREATHTEK UBT KITOct 26, 2017InjuryOtsuka3000718406-2015-00007
Event type breakdown
Injury5
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.