Test, Urea (breath Or Blood)
Microbiology · 21 CFR 866.3110
Recent MDR events
24 adverse event reports on file
- ID KIT TWOMay 26, 2026InjuryMeridian Bioscience Israel3005772418-2026-00001
- IDKIT TWOJan 23, 2025InjuryMeridian Bioscience Israel3005772418-2025-00001
- CARDIOSAVE HYBRID, TYPE I PLUGSep 24, 2024MalfunctionDatascope Corp.2249723-2024-0003894
- CARBON 13 TESTDec 6, 2022UnknownMW5113684
- BREATHTEK UBT KITOct 24, 2017InjuryOtsuka America Pharmaceuticals, Inc.3000718406-2017-00003
- BREATHTEK UBT KITJun 2, 2017InjuryOtsuka Pharmaceuticals3000718406-2017-00002
- BREATHTEK UBT KITSep 29, 2016InjuryOtsuka America Pharmaceuticals, Inc.3000718406-2016-00002
- BREATHTEKJul 8, 2016InjuryOtsuka Pharmaceutical3000718406-2016-00001
- BREATH TEK UBT KITApr 14, 2015OtherOtsuka America Pharmaceuticals Inc.3000718406-2015-00005
- BREATH TEK UBT KITApr 7, 2015InjuryOtsuka America Pharmaceutical Inc.3000718406-2015-00004
Event type breakdown
Recalls
2 recall events for this product code
- Exalenz Bioscience LtdTerminatedOct 12, 2011
IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Biosci
The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted).
Z-0042-2012 · View FDA record ↗ - Meretek Diagnostics, Inc.TerminatedOct 4, 2007
BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
Z-0003-2008 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
17 clearances for this product code
- Meridian Bioscience Israel , Ltd.Dec 19, 2022
K221896 · BreathID Hp System
- Meridian Bioscience Israel , Ltd.Nov 10, 2022
K223185 · BreathID® Smart System
- Meridian Bioscience Israel , Ltd.Jun 23, 2022
K220494 · BreathID Hp Lab System, BreathID Smart System
- Exalenz Bioscience , Ltd.Feb 6, 2020
K193610 · BreathID Smart System
- Exalenz Bioscience , Ltd.Mar 8, 2018
K173772 · BreathID Hp System
- Exalenz Bioscience , Ltd.Mar 8, 2018
K173777 · BreathID Hp Lab System
- Exalenz Bioscience , Ltd.Oct 31, 2016
K162150 · BreathID Hp Lab System
- Exalenz Bioscience , Ltd.May 22, 2013
K130524 · BREATHID HP SYSTEM