FDA.reportPublic FDA data

Urea IVD, kit, enzyme spectrophotometry

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using an enzyme spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia.
GUDID devices
60
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03610230005040ABX PENTRA UREA CPHORIBA ABX SAS12200016412016-08-23
04015630911790Kinetic UV assay for ureaurea nitrogenRoche Diagnostics GmbH119294702162016-09-20
04015630911806Kinetic UV assay for ureaurea nitrogenRoche Diagnostics GmbH119294882162016-09-20
04015630920464UreaBUNRoche Diagnostics GmbH44607151902016-09-20
04015630921966UREABUNRoche Diagnostics GmbH46576161902016-09-20
04015630925131UreaBUNRoche Diagnostics GmbH51718731902016-09-20
04015630991372Kinetic UV assay for ureaurea nitrogenRoche Diagnostics GmbH117296912162016-09-20
00811727015747Pointe BUN on BS480HORIBA INSTRUMENTS INCORPORATED14-B7552-6002020-05-28
03661540203800ENVOY 500 BUN REAGENT KITVITALSCIENTIFIC554452016-09-24
03661540216800UREA UV SLVITALSCIENTIFICURSL-02502016-09-24
00811403011650BUN ReagentDiamond Diagnostics Inc.BK-472482D2023-06-12
03661540200281EON 100 BUN/Urea REAGENTVITALSCIENTIFIC774452016-09-24
03661540200632EON 300 BUN/UREA REAGENTVITALSCIENTIFIC794452016-09-24
00811727016058Pointe BUN ReagentHORIBA INSTRUMENTS INCORPORATED16-B7552-5912021-01-30
03610230007228Yumizen C1200 Uric acidHORIBA ABX SAS13000238702020-08-31
03610230007211Yumizen C1200 UreaHORIBA ABX SAS13000238692020-08-28
00386100001988BUN Reagent Kit MEDICA CORPORATION10202-42019-02-14
07613336121603Urea/BunRoche Diagnostics GmbH080588061902020-03-05
05055273216172UREARANDOX LABORATORIES LIMITEDUR2202019-06-03
15099590010317AUBeckman Coulter, Inc.OSR61342016-09-24
15099590010386AUBeckman Coulter, Inc.OSR61412016-09-24
15099590020163AUBeckman Coulter, Inc.OSR62342016-09-24
15099590050405AUBeckman Coulter, Inc.OSR65412016-09-24
15099590060114AUBeckman Coulter, Inc.OSR66342016-09-24
15099590060213AUBeckman Coulter, Inc.OSR66412016-09-24
15099590233082SynchronBeckman Coulter, Inc.4427502016-08-24
15099590233495SynchronBeckman Coulter, Inc.4724822016-08-24
15099590575274SynchronBeckman Coulter, Inc.4428202016-08-24
00842768014116Dimension® Flex® reagent cartridge BUNSiemens Healthcare Diagnostics Inc.104449692016-09-24
00842768015601Dimension Vista® Flex® reagent cartridge BUNSiemens Healthcare Diagnostics Inc.104451592016-09-24
00845275000351Thermo Scientific Infinity™Fisher DiagnosticsTR124212016-09-16
00851445007082GENCHEM™ UREAGENCHEM INCGEN-BUN R12016-09-19
00817302020359CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 BUN REAGENT KIT Product No. ST252CAROLINA LIQUID CHEMISTRIES CORPORATIONST2522016-09-01
00817302020366CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT BL-252CAROLINA LIQUID CHEMISTRIES CORPORATIONBL2522016-09-01
00817302020373CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT AU-252CAROLINA LIQUID CHEMISTRIES CORPORATIONAU-2522016-09-01
00817302020380CAROLINA LIQUID CHEMISTRIES CORP.® BUN UREA NITROGEN REAGENT CC252CAROLINA LIQUID CHEMISTRIES CORPORATIONCC2522016-09-01
00817302022971CAROLINA LIQUID CHEMISTRIES CORP.® BUN REAGENT PRODUCT NO. DT252CAROLINA LIQUID CHEMISTRIES CORPORATIONDT2522016-10-17
00817439020284BUN/BS480Medtest Dx, Inc.BUN4802016-09-27
00817439020291BUN/Polychem 180Medtest Dx, Inc.BUN5052016-09-27
00817439020307BUN/BS200Medtest Dx, Inc.BUN6002016-09-27
00811727010537POINTE SCIENTIFIC BUN LiquidHORIBA INSTRUMENTS INCORPORATEDB7552-1502016-08-31
00811727010544POINTE SCIENTIFIC BUN LiquidHORIBA INSTRUMENTS INCORPORATEDB7552-4502016-08-31
00811727010551POINTE SCIENTIFIC BUN LiquidHORIBA INSTRUMENTS INCORPORATEDB7552-6252016-08-31
00811727010568POINTE SCIENTIFIC BUN (Berthelot)HORIBA INSTRUMENTS INCORPORATEDB7551-1202016-08-31
00811727013439POINTE SCIENTIFIC BUNHORIBA INSTRUMENTS INCORPORATED12-B7552-1502016-08-31
00811727013873Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-B7552-R1-1202016-08-31
00811727013880Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-B7552-R1-5002016-08-31
00811727013897Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-B7552-R2-1252016-08-31
00811727013903Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-B7552-R2-302016-08-31
00811727014658Pointe Scientific, Inc. BUNHORIBA INSTRUMENTS INCORPORATEDHB752-25002016-08-31
00811727014955Pointe Scientific, Inc. BUNHORIBA INSTRUMENTS INCORPORATEDOB952-4822016-08-31
00812137011916Urea Nitrogen Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.R1 x 500mL, R2 x 125mL2016-10-12
00657498001073Urea Nitrogen (BUN) Liqui-UV®STANBIO LABORATORY, L.P.2020-4302016-09-23
00657498001080Urea Nitrogen (BUN) Liqui-UV®STANBIO LABORATORY, L.P.2020-5002016-09-23
00657498001097Urea Nitrogen (BUN) TestSTANBIO LABORATORY, L.P.0580-2502016-09-24
00657498001622Sirrus® Urea Nitrigen (BUN) Liqui-UV®STANBIO LABORATORY, L.P.S2020-6002016-09-23
00630414517513ADVIA® Chemistry UN Urea Nitrogen ReagentsSiemens Healthcare Diagnostics Inc.103090512016-09-24
00630414551142Azostix® Reagent StripsSiemens Healthcare Diagnostics Inc.103240602016-09-24
00630414553214ADVIA® Chemistry UN_c Urea Nitrogen Reagents, ConcentratedSiemens Healthcare Diagnostics Inc.102833492016-09-24
00630414596471Atellica CH UN_cSiemens Healthcare Diagnostics Inc.110975932017-12-22