Albumin Reagent

Primary DI
00812137011848
Brand
Albumin Reagent
Company
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model
500 mL
Catalog number
501-397
Device description
For the quantitative determination of Albumin in serum.
Published
2016-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CIXBromcresol Green Dye-Binding, Albumin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIXBromcresol Green Dye-Binding, AlbuminClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812137011848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812137011848008121370118488121370118480812137011848

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004533328quality@cdsolinc.com

Regulatory Flags#

DUNS number
048144997
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812137012005LDH Reagent SetR1 x 500mL, R2 x 125mL501-4132016-10-12
00812137011855Alkaline Phosphatase Reagent SetR1 x 500 mL, R2 x 125 mL501-3982016-10-12
00812137011886AST (SGOT) Reagent SetR1 x 500mL, R2 x 125mL501-4012016-10-12
00812137011961Creatinine Reagent SetR1 x 500mL, R2 x 125mL501-4092016-10-12
00812137012098CRP Reagent SetR1 x 50mL, R2 x 50mL501-4352016-10-12
00812137012142CRP Calibrator Set5 x 2mL502-1542016-10-12
00812137012159CRP Control SetL1 x 3 x 3mL, L2 x 3 x 3mL502-1552016-10-12
00812137012197Multi-Analyte Lipid Control SetL1 x 3mL, L2 x 3mL, L3 x 3mL502-1602016-10-12
00812137012111Chemistry Calibrator Set10 x 5mL, 1 x 50mL502-1512016-10-12
00812137012128Chemistry Control Level I Set10 x 5mL502-1522016-10-12
00812137012135Chemistry Control Level II Set10 x 5mL502-1532016-10-12
00001812701208Triglycerides Reagent500mL501-4172016-10-12
00812137010254CDS-LTX CONTROL6 x 16 mL502-0062016-09-08
00812137010261CDS-LTX PRIMER6 x 16mL502-0072016-09-08
00812137011947Carbon Dioxide Reagent120mL501-4072016-10-12
00812137011916Urea Nitrogen Reagent SetR1 x 500mL, R2 x 125mL501-4042016-10-12
00081213701184Albumin Reagent500 mL501-3972016-10-12
00812137010216Boule Con-Diff Tri-Level6 x 4.5mL501-6052016-09-02
00812137010223Boule Cal1 x 3.0mL501-6062016-09-06
00812137010230Boule Con-Diff Tri-Level9 x 4.5mL501-6072016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654140Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2026-03-18
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10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
00380740155346AlinityABBOTT IRELANDCIX2024-08-15
00380740155353AlinityABBOTT IRELANDCIX2024-08-15
00380740155872ARCHITECTABBOTT IRELANDCIX2024-08-15
00380740155889ARCHITECTABBOTT IRELANDCIX2024-08-15
00850053916007IDG/SanzayIDG/SANZAY CorporationCIX2023-12-18
10673486001013Albumin Reagent SetTECO DIAGNOSTICSCIX2023-07-07
10673486001020Albumin -BCG method TC-MatrixTECO DIAGNOSTICSCIX2023-07-07
00811727016003Pointe Albumin Reagent HORIBA INSTRUMENTS INCORPORATEDCIX2021-01-30
00811727015693Pointe Albumin on BS480 AnalyzerHORIBA INSTRUMENTS INCORPORATEDCIX2020-05-28
10758750031771VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CIX2020-05-16
03610230006825Yumizen C1200 AlbuminHORIBA ABX SASCIX2020-05-06
07613336120941Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
07613336120958Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
00380740161644ARCHITECTAbbott GmbHCIX2019-11-15
00386100002145ALB Reagent KitMEDICA CORPORATIONCIX2019-02-14
00380740121716AlinityAbbott GmbHCIX2018-07-11
00852169008010ClearChem Diagnostics Inc. AlbuminCLEARCHEM DIAGNOSTICS INC.CIX2018-04-30
00817274022696JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2018-04-26
00630414596501Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2017-12-22
05060500091682Synermed®INFRARED LABORATORY SYSTEMS LLCCIX2017-02-28
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224CAROLINA LIQUID CHEMISTRIES CORPORATIONCIX2016-10-17
00081213701184Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00817274022313JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2016-10-11
00817439020093Albumin / BS480Medtest Dx, Inc.CIX2016-09-27
00817439020109AlbuminMedtest Dx, Inc.CIX2016-09-27