FDA.reportPublic FDA data

GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent

Primary DI
00851445007075
Brand
GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent
Company
GENCHEM INC
Model
GEN-BUN3
Catalog number
GEN-BUN3
Device description
10/17/2022
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDSELECTRODE, ION SPECIFIC, UREA NITROGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDSElectrode, Ion Specific, Urea NitrogenClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040973000BUN REAGENTGenchem, Inc.2004-12-27CDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851445007075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851445007075008514450070758514450070750851445007075

GMDN Terms#

Term, Definition table
TermDefinition
Urea IVD, reagentA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)529-7125lorlow@genchem.org

Regulatory Flags#

DUNS number
193856866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851445007006GENCHEM™ Albumin ReagentGEN-ALBGEN-ALB2016-09-19
00851445007013GENCHEM™ Albumin ReagentGEN-ALB-GGEN-ALB-G2016-09-19
00851445007020GENCHEM™ Alkaline PhosphataseGEN-ALP R1GEN-ALP R12016-09-19
00851445007037GENCHEM™ Alkaline PhosphataseGEN-ALP R2GEN-ALP R22016-09-19
00851445007044GENCHEM™ Amylase ReagentGEN-AMYGEN-AMY2016-09-19
00851445007099GENCHEM™Calcium, Azo Dye ReagentGEN-CA3GEN-CA32016-09-19
00851445007211GENCHEM™ Glucose Oxidase ReagentGEN-GLU3GEN-GLU32016-09-19
00851445007228GENCHEM™ Glucose Oxidase ReagentGEN-GLU LXGEN-GLU LX2016-09-19
00851445007235GENCHEM™ Glucose ReagentGEN-GLU4GEN-GLU42016-09-19
00851445007051GENCHEM™ AST/SGOTGEN-AST R1GEN-AST R12016-09-19
00851445007068GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGEN-BUN LXGEN-BUN LX2016-09-19
00851445007082GENCHEM™ UREAGEN-BUN R1GEN-BUN R12016-09-19
00851445007105GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1GEN-CAL 1GEN-CAL 12016-09-19
00851445007112GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 2GEN-CAL 2GEN-CAL 22016-09-19
00851445007129GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 3GEN-CAL 3GEN-CAL 32016-09-19
00851445007136GENCHEM™ CK-NAC ReagentGEN-CK R1GEN-CK R12016-09-19
00851445007143GENCHEM™ CK-NAC ReagentGEN-CK R2GEN-CK R22016-09-19
00851445007150GENCHEM™ CO2 Acid ReagentGEN-CO2ACIDGEN-CO2ACID2016-09-19
00851445007167GENCHEM™ CO2 Acid ReagentGEN-CO2ALKGEN-CO2ALK2016-09-19
00851445007174GENCHEM™ Creatinine Test ReagentGEN-CREA R1(Base)GEN-CREA R1(Base)2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403011124BUN ReagentDiamond Diagnostics Inc.CDS2023-06-05
10054749005519i-STATABBOTT POINT OF CARE INC.CDS2020-05-01
00385480183420NOVANOVA BIOMEDICAL CORPORATIONCDS2017-04-24
00385480485968STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2017-04-21
04015630018123cobas b 221 GLU/LAC/UREA (BUN) CassetteRoche Diagnostics GmbHCDS2016-09-24
00856522006033H4 CartridgeLifehealthCDS2016-09-24
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-22
00385480087964NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480176125NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480539852NovaNOVA BIOMEDICAL CORPORATIONCDS2016-09-20
10385480087961NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480131926NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480131940NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480132039NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480141826NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480142441NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480145756NovaNOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480146104NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480148306NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480148443NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480161534NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20