FDA.reportPublic FDA data

DImension Vista® Retinol binding Protein

Primary DI
00842768006227
Brand
DImension Vista® Retinol binding Protein
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445907
Catalog number
K7066
Device description
For the quantitative measurement of retinol binding protein in human serum and plasma on the Dimension Vista® System
Published
2020-09-24
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
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
00842768006227PrimaryGS10
00842768020148Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006227008427680062278427680062270842768006227
00842768020148008427680201488427680201480842768020148

GMDN Terms#

Term, Definition table
TermDefinition
Retinol binding protein IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of retinol binding protein in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24

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
06971674869368BIOBASEBiobase 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
05700572034780Poly Rb A-Hu Retinol-Binding ProteinAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZS2020-09-17
00813545026448RBP ELISA ASSAY 96 TEST KIT SCIMEDX CORPORATIONCZS2016-09-21