FDA.reportPublic FDA data

UREA

Primary DI
05055273216172
Brand
UREA
Company
RANDOX LABORATORIES LIMITED
Model
UR220
Catalog number
UR220
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923506000UREA KITRandox Laboratories, Ltd.1993-09-27CDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273216172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273216172050552732161725055273216172

GMDN Terms#

Term, Definition table
TermDefinition
Urea IVD, kit, enzyme spectrophotometryA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654119Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2026-03-18
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.CDQ2026-01-23
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
00850053916069IDG/SanzayIDG/SANZAY CorporationCDQ2024-01-09
10673486001228Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001235Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480TECO DIAGNOSTICSCDQ2023-07-21
10673486001242Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001259Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
00811727016058Pointe BUN ReagentHORIBA INSTRUMENTS INCORPORATEDCDQ2021-01-30
03610230007211Yumizen C1200 UreaHORIBA ABX SASCDQ2020-08-28
00811727015747Pointe BUN on BS480HORIBA INSTRUMENTS INCORPORATEDCDQ2020-05-28
07613336121603Urea/BunRoche Diagnostics GmbHCDQ2020-03-05
00380740161774ARCHITECTAbbott GmbHCDQ2020-01-25
00380740161781ARCHITECTAbbott GmbHCDQ2020-01-25
00386100001988BUN Reagent Kit MEDICA CORPORATIONCDQ2019-02-14
00380740121662AlinityAbbott GmbHCDQ2018-08-31
00380740121679AlinityAbbott GmbHCDQ2018-08-31
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)CLEARCHEM DIAGNOSTICS INC.CDQ2018-04-30
00817274022672JAS DiagnosticsDREW SCIENTIFIC, INC.CDQ2018-04-26
00630414596471Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2017-12-22
05060500091736Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091743Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091750Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091767Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091774Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091781Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091798Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28