FDA.reportPublic FDA data

GENCHEM™ Albumin Reagent

Primary DI
00851445007006
Brand
GENCHEM™ Albumin Reagent
Company
GENCHEM INC
Model
GEN-ALB
Catalog number
GEN-ALB
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
CJWBROMCRESOL PURPLE DYE-BINDING, ALBUMIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021636000ALBUMIN REAGENTIntersect Systems, Inc.2002-07-17CJW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851445007006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851445007006008514450070068514450070060851445007006

GMDN Terms#

Term, Definition table
TermDefinition
Albumin 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 quantitative measurement of albumin 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
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
00851445007075GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGEN-BUN3GEN-BUN32016-09-19
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
00630414654003Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2026-03-18
00380740155285AlinityABBOTT IRELANDCJW2024-08-15
00380740155292AlinityABBOTT IRELANDCJW2024-08-15
00380740155483ARCHITECTABBOTT IRELANDCJW2024-08-15
00380740155490ARCHITECTABBOTT IRELANDCJW2024-08-15
08058056681973Albumin BCP (6x20 mL)SENTINEL CH. SPACJW2020-02-24
08058056681980Albumin BCP (6x50 mL)SENTINEL CH. SPACJW2020-02-24
00380740121723AlinityAbbott GmbHCJW2018-07-11
00630414595825Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2017-12-22
00842768005343Dimension® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00842768015021Dimension Vista® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00630414947402ADVIA® Chemistry Albumin BCP ReagentsSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00630414947419ADVIA® Chemistry Albumin BCP ReagentsSiemens Healthcare Diagnostics Inc.CJW2016-09-24
EABA40000031Piccolo Liver Panel PlusABAXIS, INC.CJW2016-09-23
EABA40000261Piccolo Hepatic Function PanelABAXIS, INC.CJW2016-09-23
EABA40000271Piccolo Renal Function PanelABAXIS, INC.CJW2016-09-23
EABA40000281Piccolo Comprehensive Metabolic PanelABAXIS, INC.CJW2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CJW2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CJW2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CJW2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CJW2016-09-23
04015630928064Albumin BCPRoche Diagnostics GmbHCJW2016-09-20
04015630990634AlbuminBCP AlbuminBCPRoche Diagnostics GmbHCJW2016-09-20
05055273200034ALBRANDOX LABORATORIES LIMITEDCJW2016-09-16
00817302020229CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
15099590233341SynchronBeckman Coulter, Inc.CJW2016-08-24
15099590625719SynchronBeckman Coulter, Inc.CJW2016-08-24
00380740012816ARCHITECTABBOTT LABORATORIESCJW2016-06-06