FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674869368
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:18mL×1 R2:6mL×1
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CZSRetinol-Binding Protein, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CZSRetinol-Binding Protein, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674869368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674869368069716748693686971674869368

GMDN Terms#

Term, Definition table
TermDefinition
Retinol-binding protein IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of retinol-binding protein in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420046355
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971674866664BIOBASER1:60mL×2 R2:20mL×22023-07-22
06971674866671BIOBASER1:18mL×4 R2:6mL×42023-07-22
06971674866688BIOBASER1:18mL×1 R2:6mL×12023-07-22
06971674867920BIOBASECalibrator: 1mL×12023-07-22
06971674868255BIOBASEControl: 1mL×12023-07-22
06971674866190BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866206BIOBASER1:40mL×2 R2:20mL×22023-07-22
06971674866213BIOBASER1:20mL×4 R2:10mL×42023-07-22
06971674866220BIOBASER1:20mL×1 R2:10mL×12023-07-22
06971674866237BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866244BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866251BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674868231BIOBASEControl:1mL×12023-07-22
06971674867272BIOBASER1:60mL×2 R2:20mL×22023-07-24
06971674867289BIOBASER1:18mL×4 R2:6mL×42023-07-24
06971674867296BIOBASER1:18mL×1 R2:6mL×12023-07-24
06971674867302BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867319BIOBASER1:90mL×1 R2:30mL×12023-07-24
06971674867326BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867777BIOBASECalibrator:1mL×12023-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474043914Retinol binding Protein (RBP)/RBP4 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCZS2023-08-31
00840239043917Retinol binding Protein (RBP)/RBP4 ELISADRG International IncCZS2023-08-25
06971674868033BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CZS2023-07-24
06971674868385BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CZS2023-07-24
06971674869344BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CZS2023-07-24
06971674869351BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CZS2023-07-24
04050598010499Retinol-binding protein RBP/RBP4 ELISAImmundiagnostik AGCZS2023-06-21
04050598010505Retinol-binding protein RBP/RBP4 ELISAImmundiagnostik AGCZS2023-06-21
00842768011856N Antiserum to Human RBPSiemens Healthcare Diagnostics Products GmbHCZS2020-09-24
00842768006227DImension Vista® Retinol binding ProteinSiemens Healthcare Diagnostics Products GmbHCZS2020-09-24
05700572034780Poly Rb A-Hu Retinol-Binding ProteinAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZS2020-09-17
00813545026448RBP ELISA ASSAY 96 TEST KIT SCIMEDX CORPORATIONCZS2016-09-21