Retinol binding Protein (RBP)/RBP4 ELISA

Basic Information

• Brand Name: Retinol binding Protein (RBP)/RBP4 ELISA
• Primary DI: 00840239043917
• Version / Model: EIA-4391
• Catalog Number: EIA-4391
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-25
• Public Version: 1
• Public Version Date: 2023-09-04
• Public Version Status: New
• Public Device Record Key: 95d34ff8-7c8b-46d8-b2a6-0ccb9118a441

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CZS	Retinol-Binding Protein, Antigen, Antiserum, Control	Immunology	866.5765	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53971	Retinol binding protein IVD, kit, nephelometry/turbidimetry	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239043917	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius