FDA.reportPublic FDA data

Retinol binding Protein (RBP)/RBP4 ELISA

Primary DI
00840239043917
Brand
Retinol binding Protein (RBP)/RBP4 ELISA
Company
DRG International Inc
Model
EIA-4391
Catalog number
EIA-4391
Device description
This assay is an enzyme immunoassay intended for the quantitative determination of free retinol-binding protein RBP/RBP4 as well as RBP4 complexed with transthyretin in plasma, serum and urine
Published
2023-08-25
Public version status
New
Distribution status
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
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
00840239043917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239043917008402390439178402390439170840239043917

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
9735647555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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
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
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