FDA.reportPublic FDA data

Urea IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.
GUDID devices
50
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850053916069IDG/SanzayIDG/SANZAY Corporation12024-01-09
05204309031245UreaMEDICON HELLAS S.A.1418-00272026-04-27
05204309161737UreaMEDICON HELLAS S.A.1419-00222026-04-27
10673486001228Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent SetTECO DIAGNOSTICSB549-1502023-07-21
10673486001235Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480TECO DIAGNOSTICSB549-6202023-07-21
10673486001242Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSB550-2402023-07-21
10673486001259Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSB550-4002023-07-21
10673486001266Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)TECO DIAGNOSTICSB551-662023-07-21
10673486001273Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)TECO DIAGNOSTICSB551-1322023-07-21
10758750004362VITROSORTHO-CLINICAL DIAGNOSTICS, INC.81022042016-08-23
EABA40000331Piccolo Kidney CheckABAXIS, INC.400-00332016-09-23
00380740161774ARCHITECTAbbott GmbH7D75-222020-01-25
00380740161781ARCHITECTAbbott GmbH7D75-322020-01-25
05055273206852UREARANDOX LABORATORIES LIMITEDUR2202016-09-24
05055273206869UREARANDOX LABORATORIES LIMITEDUR2212016-09-24
05055273206890BUNRANDOX LABORATORIES LIMITEDUR28212016-09-24
05055273206906UREARANDOX LABORATORIES LIMITEDUR38252016-09-24
05055273206913UREARANDOX LABORATORIES LIMITEDUR38732016-09-24
05055273206920UREARANDOX LABORATORIES LIMITEDUR4462016-09-24
05055273206937UREARANDOX LABORATORIES LIMITEDUR4562016-09-24
05055273206944UREARANDOX LABORATORIES LIMITEDUR4572016-09-24
05055273206951UREARANDOX LABORATORIES LIMITEDUR79752016-09-24
05055273206968UREARANDOX LABORATORIES LIMITEDUR79762016-09-24
05055273206975UREARANDOX LABORATORIES LIMITEDUR97292016-09-24
05055273209600UREARANDOX LABORATORIES LIMITEDUR83342016-09-24
05060500091736Synermed®INFRARED LABORATORY SYSTEMS LLCUV190-12002017-02-28
05060500091743Synermed®INFRARED LABORATORY SYSTEMS LLCUV190-R2017-02-28
05060500091750Synermed®INFRARED LABORATORY SYSTEMS LLCUV190-X2017-02-28
05060500091767Synermed®INFRARED LABORATORY SYSTEMS LLCUV190-WK2017-02-28
05060500091774Synermed®INFRARED LABORATORY SYSTEMS LLCUV190-9112017-02-28
05060500091781Synermed®INFRARED LABORATORY SYSTEMS LLCUV191-L2017-02-28
05060500091798Synermed®INFRARED LABORATORY SYSTEMS LLCUV192-L2017-02-28
05060500091804Synermed®INFRARED LABORATORY SYSTEMS LLCUV193-L2017-02-28
00851445007068GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGENCHEM INCGEN-BUN LX2016-09-19
00851445007075GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGENCHEM INCGEN-BUN32016-09-19
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)CLEARCHEM DIAGNOSTICS INC.BUN10702018-04-30
00852223007119UREA NITROGEN (BERTHELOT)STERLING DIAGNOSTICS INC2290-L2016-09-14
00852223007126UREA NITROGEN (BERTHELOT)STERLING DIAGNOSTICS INC2290-02016-09-14
00857969006266ACEALFA WASSERMANN, INC.SA20242016-09-24
00817238010820Bun Rate ReagentCLINIQA CORPORATIONR820432016-08-15
00817238011193BUN Reagent, LiquidCLINIQA CORPORATIONR845332016-09-21
00817238011391BUN Rate ReagentCLINIQA CORPORATIONR820422016-09-21
00817302020397CAROLINA LIQUID CHEMISTRIES CORP.™ BUN REAGENT 88806CAROLINA LIQUID CHEMISTRIES CORPORATION888062016-09-01
00811727012593Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHB952-10202016-08-31
00811727012951Pointe ScientificHORIBA INSTRUMENTS INCORPORATEDHB952-6542016-08-31
00811727013378Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHB752-5102016-08-31
00380740012991ARCHITECTABBOTT LABORATORIES7D75-212016-09-09
00380740013004ARCHITECTABBOTT LABORATORIES7D75-312016-09-09
00380740121662AlinityAbbott GmbH08P16202018-08-31
00380740121679AlinityAbbott GmbH08P16302018-08-31