Prealbumin

Basic Information

• Brand Name: Prealbumin
• Primary DI: 04015630928804
• Version / Model: 5950902190
• Catalog Number: 5950902190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-18
• Public Version: 1
• Public Version Date: 2021-01-26
• Public Version Status: New
• Public Device Record Key: f6064704-927e-41e3-9619-b01c7dc4a274

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
JZJ	PREALBUMIN, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53957	Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of prealbumin (transthyretin) 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	04015630928804	GS1