Urease And Glutamic Dehydrogenase, Urea Nitrogen
FDA product code CDQ · Class II (moderate risk) · 21 CFR 862.1770 · Clinical Chemistry
117510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Em Diagnostic Systems, Inc. 9
- Sigma Diagnostics, Inc. 5
- Boehringer Mannheim Corp. 4
- Emd Chemicals, Inc. 4
- Abbott Laboratories 4
- Data Medical Associates, Inc. 3
- Diagnostic Chemicals, Ltd. (Usa) 3
- Trace Scientific , Ltd. 3
- American Research Products Co. 3
- Diagnostic Chemicals , Ltd. 3
- Olympus Corp. 3
- Instrumentation Laboratory CO 2
- Beckman Instruments, Inc. 2
- Union Carbide Corp. 2
- Pointe Scientific, Inc., 2
- American Monitor Corp. 2
- Macomb Chemical Co. 2
- Wako Chemicals USA, Inc. 2
- American Scientific Products 2
- Medical Analysis Systems, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203771 | Urea Nitrogen2CDQ · Traditional | Abbott Ireland Diagnostics Division | 05/31/2022SE |
| K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerCDQ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/02/2014SE |
| K110675 | Easyra Urea Nitrogen and Creatinine ReagentsCDQ · Traditional | Medica Corp. | 04/21/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | Thermofisher Scientific OY | 05/29/2008SE |
| K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPCDQ · Traditional | Horiba Abx | 10/12/2007SE |
| K060120 | Teco CX3 Reagent Set for Synchron CX SystemCDQ · Traditional | Teco Diagnostics | 03/27/2006SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | Hemagen Diagnostics, Inc. | 06/30/2004SE |
| K024182 | Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsCDQ · Traditional | Precision Systems, Inc. | 03/03/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | Elan Diagnostics | 07/12/2002SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | Hemagen Diagnostics, Inc. | 10/15/2001SE |
| K012260 | Wiener Lab. Urea UV Cinetica AaCDQ · Traditional | Wiener Laboratories Saic | 09/19/2001SE |
| K011596 | Urea Nitrogen (Bun) Liquid ReagentCDQ · Traditional | Jas Diagnostic, Inc. | 07/17/2001SE |
| K002694 | UREA-L3K Assay, Catalogue Number 283-17/30CDQ · Special | Diagnostic Chemicals , Ltd. | 09/15/2000SE |
| K000958 | Atac Pak Bun Reagent and Atac Calibrator KitsCDQ · Traditional | Elan Holdings, Inc. | 05/24/2000SE |
| K993925 | Wako L-Type Un TestCDQ · Traditional | Wako Chemicals USA, Inc. | 04/03/2000SE |
| K993178 | UREA-L3K Assay, Catalogue Number 283-17/10/30/50CDQ · Traditional | Diagnostic Chemicals , Ltd. | 10/18/1999SE |
| K992800 | Sigma Diagnostics Infinity Bun Reagent, Models 63-25, 63-100P, 63-500P, 63-2000P, 64-20…CDQ · Traditional | Sigma Diagnostics, Inc. | 09/28/1999SE |
| K990980 | Bun, Model Bu 104-01CDQ · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K982236 | Sigma Diagnostics Infinity Bun Reagent KitCDQ · Traditional | Sigma Diagnostics, Inc. | 08/05/1998SE |
| K981918 | UreaCDQ · Traditional | Abbott Laboratories | 07/28/1998SE |
| K981123 | UreaCDQ · Traditional | Trace Scientific , Ltd. | 04/24/1998SE |
| K981106 | Urea Nitrogen (Bun) Liquid ReagentCDQ · Traditional | Teco Diagnostics | 04/16/1998SE |
| K980057 | Careside BunCDQ · Traditional | Exigent Diagnostics, Inc. | 02/05/1998SE |
| K974337 | Il Test Urea NitrogenCDQ · Traditional | Instrumentation Laboratory CO | 12/17/1997SE |
| K973931 | Urea-Sl Assay Catalogue Number 239-10, 239-30CDQ · Traditional | Diagnostic Chemicals , Ltd. | 11/24/1997SE |
| K971309 | UreaCDQ · Traditional | Derma Media Lab., Inc. | 08/01/1997SE |
| K972671 | Bun (Liquid) Reagent SetCDQ · Traditional | Pointe Scientific, Inc., | 07/20/1997SE |
| K971967 | BunCDQ · Traditional | Carolina Liquid Chemistries Corp. | 06/17/1997SE |
| K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)CDQ · Traditional | Trace America, Inc. | 05/27/1997SE |
| K962418 | Urea Nitrogen (Bun) Liqui-UvCDQ · Traditional | Stanbio Laboratory | 12/26/1996SE |
| K960115 | Hichem Bun/Urea Reagent KitCDQ · Traditional | Elan Pharma, Inc. | 03/29/1996SE |
| K954000 | Roche Reagent for BunCDQ · Traditional | Roche Diagnostic Systems, Inc. | 10/25/1995SE |
| K952742 | Blood Urea Nitrogen Reagent SystemCDQ · Traditional | Medical Diagnostic Technologies, Inc. | 08/11/1995SE |
| K942984 | Bun ReagentCDQ · Traditional | American Research Products Co. | 03/01/1995SE |
| K944250 | Urea Nitrogen ReagentCDQ · Traditional | Olympus Corp of America | 02/08/1995SE |
| K934533 | BUN-300/BUN-500 Urea Nitrogen ReagentCDQ · Traditional | Horizon Diagnostics, Inc. | 11/26/1993SE |
| K923506 | Urea KitCDQ · Traditional | Randox Laboratories, Ltd. | 09/27/1993SE |
| K932161 | Urea Nitrogen Test Item Number 65408CDQ · Traditional | Em Diagnostic Systems, Inc. | 09/08/1993SE |
| K931745 | Olympus Reply Urea Nitrogen ReagentCDQ · Traditional | Olympus Corp. | 08/19/1993SE |
| K925002 | Urea Nitrogen TestCDQ · Traditional | Em Diagnostic Systems, Inc. | 01/04/1993SE |
| K924693 | Olympus Bun ReagentCDQ · Traditional | Olympus Corp. | 11/25/1992SE |
| K923035 | Miles Urine Urea Nitrogen MethodCDQ · Traditional | Heraeus Kulzer, Inc. | 09/09/1992SE |
| K922597 | Olympus Urea Nitrogen (Bun) ReagentCDQ · Traditional | Olympus Corp. | 07/10/1992SE |
| K914877 | Il Test(Tm) Urea NitrogenCDQ · Traditional | Instrumentation Laboratory CO | 03/11/1992SE |
| K911248 | Synermed Urea Nitrogen Reagent KitCDQ · Traditional | Synermed, Inc. | 06/03/1991SE |
| K905602 | Eclipse Ica BunCDQ · Traditional | Biotope, Inc. | 01/16/1991SE |
| K903334 | Urea Nitrogen TestCDQ · Traditional | Em Diagnostic Systems, Inc. | 09/07/1990SE |
| K902175 | Coulter Urea Nitrogen ReagentCDQ · Traditional | Coulter Corp. | 06/12/1990SE |
| K901123 | Chem 1 Clinical Analyzer Urine Urea NitrogenCDQ · Traditional | Technicon Instruments Corp. | 05/10/1990SE |
| K900394 | Amresco Bun-Kinetic Reagents Products #7583CDQ · Traditional | American Research Products Co. | 04/11/1990SE |
| K894836 | Dart Urea NitrogenCDQ · Traditional | Coulter Electronics, Inc. | 10/30/1989SE |
| K895666 | Bun (Kinetic)CDQ · Traditional | Boehringer Mannheim Corp. | 10/27/1989SE |
| K894173 | Bun-Blood Urea Nitrogen for Manual/Auto ApplicatCDQ · Traditional | Catachem, Inc. | 09/05/1989SE |
| K894378 | Urea Nitrogen Test (Bun) Item #65408CDQ · Traditional | Em Diagnostic Systems, Inc. | 08/31/1989SE |
| K892331 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | American Monitor Corp. | 06/20/1989SE |
| K891912 | Amresco Urea Nitrogen (Bun) Reagents, Prod # 7123CDQ · Traditional | American Research Products Co. | 06/19/1989SE |
| K884987 | Urea Nitrogen Test (Bun) Item Number: SR1022CDQ · Traditional | Em Diagnostic Systems, Inc. | 01/13/1989SE |
| K881677 | Bun (Kinetic)CDQ · Traditional | Boehringer Mannheim Corp. | 06/07/1988SE |
| K881366 | Biotrol Bun Enzymatique UV H.P.CDQ · Traditional | Biotrol, USA, Inc. | 05/16/1988SE |
| K880078 | Urea Nitrogen (Bun)CDQ · Traditional | Tech-Neal Scientific, Inc. | 02/11/1988SE |
| K874477 | Easy-Test Urea Nitrogen (Bun) Item Number: 19010CDQ · Traditional | Em Diagnostic Systems, Inc. | 11/23/1987SE |
| K873532 | Paramax Urea Nitrogen ReagentCDQ · Traditional | Baxter Healthcare Corp | 11/23/1987SE |
| K873335 | Wako(Tm) Autokit Urea NCDQ · Traditional | Wako Chemicals USA, Inc. | 10/02/1987SE |
| K872484 | Modified Enzymatic Bun ReagentCDQ · Traditional | Trace Scientific , Ltd. | 08/19/1987SE |
| K871547 | Ultra-Violet Bun Reagent Kit (Rate)CDQ · Traditional | Biochemical Trade, Inc. | 06/22/1987SE |
| K870571 | Emds Urea Nitrogen (Bun) Testpacks Item #67654/95CDQ · Traditional | Em Diagnostic Systems, Inc. | 03/04/1987SE |
| K863925 | Urea Nitrogen(Bun)CDQ · Traditional | Tech-Co, Inc. | 11/24/1986SE |
| K863260 | Blood Urea Nitrogen(Bun) ProcedureCDQ · Traditional | Data Medical Associates, Inc. | 09/09/1986SE |
| K863196 | Bun (Rate) ReagentCDQ · Traditional | Sigma Diagnostics, Inc. | 08/26/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | Sterling Diagnostics, Inc. | 07/01/1986SE |
| K861666 | Blood Urea Nitrogen (Bun) ProcedureCDQ · Traditional | Data Medical Associates, Inc. | 07/01/1986SE |
| K860716 | Enzymatic Bun ReagentCDQ · Traditional | Trace Scientific , Ltd. | 04/24/1986SE |
| K860135 | Easy-Test Urea (Bun) ReagentCDQ · Traditional | Em Diagnostic Systems, Inc. | 02/21/1986SE |
| K860109 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | Technostics Intl. | 02/06/1986SE |
| K853677 | TDX Rea BunCDQ · Traditional | Abbott Laboratories | 09/16/1985SE |
| K853102 | Urease & Glutamate Dehydrogenase, Urea NitrogenCDQ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/02/1985SE |
| K852292 | Durazyme Urea NitrogenCDQ · Traditional | American Monitor Corp. | 07/08/1985SE |
| K852131 | Bun(Endpoint) ReagentCDQ · Traditional | Sigma Diagnostics, Inc. | 06/10/1985SE |
| K851513 | Ultra-Violet Bun Reagent KitCDQ · Traditional | Bio-Analytics Laboratories, Inc. | 05/20/1985SE |
| K850923 | Bun (Rate) ReagentCDQ · Traditional | Sigma Diagnostics, Inc. | 03/20/1985SE |
| K844755 | Focus Urea NitrogenCDQ · Traditional | Abbott Laboratories | 01/08/1985SE |
| K844065 | Eni Blood Urea Nitrogen ReagentCDQ · Traditional | Electro-Nucleonics Laboratories, Inc. | 11/27/1984SE |
| K843326 | Systemate Bun Hem No. 67221CDQ · Traditional | Em Diagnostic Systems, Inc. | 09/14/1984SE |
| K843057 | Urea Assay KitCDQ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/27/1984SE |
| K842242 | Urea Assay KitCDQ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/18/1984SE |
| K840064 | Urea Nitrogen Reagent SetCDQ · Traditional | Sterling Biochemical, Inc. | 06/14/1984SE |
| K840785 | Paramax Urea Nitrogen ReagentCDQ · Traditional | American Dade | 04/05/1984SE |
| K833931 | Urea Nitrogen-UvCDQ · Traditional | Seragen Diagnostics, Inc. | 01/13/1984SE |
| K832941 | Bun Liquid Stable Reagent SetCDQ · Traditional | Medical Analysis Systems, Inc. | 10/28/1983SE |
| K832749 | Easytouch Bun Reagent SetCDQ · Traditional | Worthington Diagnostic Systems | 10/14/1983SE |
| K831626 | Urea Nitrogen-Bun-Reagents B6370-11ACDQ · Traditional | American Scientific Products | 07/07/1983SE |
| K831625 | Urea Nitrogen-Bun-Reagents B6360-12CDQ · Traditional | American Scientific Products | 07/07/1983SE |
| K830241 | Ultra Chem Bun-Uv #65080-65081CDQ · Traditional | Emd Chemicals, Inc. | 04/05/1983SE |
| K830555 | Amresco Urea Nitrogen Reagent SetCDQ · Traditional | Amresco, Inc. | 03/24/1983SE |
| K823300 | Bun-Un Centrifichum 500, #65080/81CDQ · Traditional | Emd Chemicals, Inc. | 01/09/1983SE |
| K823472 | Ultra Chem Ban-Uv #65080 & 65081CDQ · Traditional | Emd Chemicals, Inc. | 12/28/1982SE |
| K823402 | Ultrachem Bun-Uv-Gem Saec APPLI.#65080&CDQ · Traditional | Emd Chemicals, Inc. | 12/26/1982SE |
| K821562 | Lancer Msa Bun Diag. KitCDQ · Traditional | Sherwood Medical Co. | 06/11/1982SE |
| K812417 | Blood Urea Nitrogen(Bun-Uv)CDQ · Traditional | Reagents Applications, Inc. | 09/09/1981SE |
| K812341 | Urea Nitrogen (Bun)CDQ · Traditional | Pointe Scientific, Inc., | 09/01/1981SE |
| K812290 | Fun-Uv System Pack TestCDQ · Traditional | Boehringer Mannheim Corp. | 08/31/1981SE |
| K810794 | A-Gent Urea NitrogenCDQ · Traditional | Abbott Laboratories | 04/01/1981SE |
| K802061 | Data-Zyme Urea Nitrogen Reagent SetCDQ · Traditional | Data Medical Associates, Inc. | 09/26/1980SE |
| K801116 | Cobas Reagent for BunCDQ · Traditional | Roche Analytical Instruments, Inc. | 06/17/1980SE |
| K800719 | Enzymatic Urea Nitrogen Reagent Set ReviCDQ · Traditional | Macomb Chemical Co. | 05/08/1980SE |
| K800529 | Centrifichem BunCDQ · Traditional | Union Carbide Corp. | 03/20/1980SE |
| K800341 | Bun ReagentCDQ · Traditional | Gilford Diagnostics | 03/12/1980SE |
| K800128 | Centrifichem BunCDQ · Traditional | Union Carbide Corp. | 02/13/1980SE |
| K781782 | BunCDQ · Traditional | Gilford Diagnostics | 01/10/1979SE |
| K780943 | Bun Test Uni-Uv Blood Urea Nitrogen TestCDQ · Traditional | Sclavo, Inc. | 07/27/1978SE |
| K780534 | Urea Nitrogen (Enzymatic)CDQ · Traditional | Macomb Chemical Co. | 05/19/1978SE |
| K780069 | Bun Reagnet SetCDQ · Traditional | Medical Analysis Systems, Inc. | 02/14/1978SE |
| K771923 | Fastchem BunCDQ · Traditional | Boehringer Mannheim Corp. | 11/11/1977SE |
| K770654 | Un, UV Delta Test AssayCDQ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/24/1977SE |
| K770315 | Bun, EnzymaticCDQ · Traditional | Icn Pharmaceuticals, Inc. | 04/05/1977SE |
| K761261 | Enzymatic Bun (Rate) Reagent KitCDQ · Traditional | Beckman Instruments, Inc. | 12/29/1976SE |
| K760414 | Enzymatic Bun Reagent KitCDQ · Traditional | Beckman Instruments, Inc. | 11/05/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2666-2023 Class II | ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and…There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some… | Siemens Healthcare Diagnostics, Inc. | 08/08/2023Open, Classified |
| Z-2362-2023 Class II | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3)…Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to… | Randox Laboratories Ltd. | 06/13/2023Open, Classified |
| Z-2062-2018 Class II | ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800…Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be… | Siemens Healthcare Diagnostics, Inc. | 03/27/2018Terminated |
| Z-1622-2016 Class II | Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in…Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE… | Siemens Healthcare Diagnostics, Inc. | 02/16/2016Terminated |
| Z-0189-2012 | Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the…The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate… | Abbott Laboratories, Inc | 10/03/2011Terminated |