Urease, Photometric, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedMay 27, 2025
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 be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1837-2025 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedNov 15, 2013
VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Z-0301-2014 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
Abaxis, Inc.
UNION CITY, CA, US
Alfa Wassermann
West Caldwell, NJ, US
Ortho Clinical Diagnostics
Singapore South West, SG
Cliniqa Corporation
San Marcos, CA, US
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Ortho-clinical Diagnostics, Inc.
ROCHESTER, NY, US
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
510(k) clearances
16 clearances for this product code
- Ortho-Clinical Diagnostics, Inc.Mar 14, 2019
K190326 · VITROS XT Chemistry Products UREA-CREA Slides
- Hitachi Chemical Diagnostics, Inc.Oct 28, 2013
K132462 · S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
- Alfa Wassermann Diagnostics Technologies, LLCMay 21, 2013
K123322 · ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
- Alfa Wassermann Diagnostic Technologies, Inc.Aug 10, 2012
K113389 · ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
- Alfa Wassermann Diagnostic Technologies, Inc.Sep 8, 2011
K103615 · ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
- Ortho-Clinical Diagnostics, Inc.Jul 20, 2000
K001885 · VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
- Cholestech Corp.Jul 24, 1997
K972012 · CHOLESTECH BUN/CREATININE TEST SYSTEM
- Johnson & Johnson Clinical Diagnostics, Inc.May 15, 1996
K961196 · EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)