Urease, Photometric, Urea Nitrogen
FDA product code CDN · Class II (moderate risk) · 21 CFR 862.1770 · Clinical Chemistry
16510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Ortho-Clinical Diagnostics 2
- Alfa Wassermann Diagnostic Technologies, Inc. 2
- Instrumentation Laboratory CO 1
- Coulter Electronics, Inc. 1
- Boehringer Mannheim Corp. 1
- Nobel Scientific Industries, Inc. 1
- The Dow Chemical Co. 1
- Em Diagnostic Systems, Inc. 1
- King Diagnostics, Inc. 1
- Prisma Systems 1
- Johnson & Johnson Clinical Diagnostics, Inc. 1
- Cholestech Corp. 1
- Alfa Wassermann Diagnostics Technologies, LLC 1
- Hitachi Chemical Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA SlidesCDN · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/14/2019SE |
| K132462 | S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreCDN · Traditional | Hitachi Chemical Diagnostics, Inc. | 10/28/2013SE |
| K123322 | Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK ReagentCDN · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 05/21/2013SE |
| K113389 | Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentCDN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 08/10/2012SE |
| K103615 | Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic…CDN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 09/08/2011SE |
| K001885 | Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1CDN · Special | Ortho-Clinical Diagnostics, Inc. | 07/20/2000SE |
| K972012 | Cholestech Bun/Creatinine Test SystemCDN · Traditional | Cholestech Corp. | 07/24/1997SE |
| K961196 | Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea)CDN · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 05/15/1996SE |
| K943042 | Bun QvetCDN · Traditional | Prisma Systems | 12/29/1994SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | King Diagnostics, Inc. | 10/13/1992SE |
| K914903 | Quickstart Urea NitrogenCDN · Traditional | Em Diagnostic Systems, Inc. | 12/31/1991SE |
| K822154 | Urea Nitrogen (Enzymatic) DeterminationCDN · Traditional | The Dow Chemical Co. | 08/05/1982SE |
| K802518 | Bun Reagent Astra 4 & 8 AnalyzersCDN · Traditional | Nobel Scientific Industries, Inc. | 11/12/1980SE |
| K792328 | Stattek BunCDN · Traditional | Boehringer Mannheim Corp. | 12/18/1979SE |
| K781253 | Bun (Urease) ReagentCDN · Traditional | Coulter Electronics, Inc. | 08/21/1978SE |
| K771442 | Multistat III Urea Nitrogen TestCDN · Traditional | Instrumentation Laboratory CO | 08/22/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1837-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-0301-2014 Class II | VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |