PREALBUMIN (PreALB)

Basic Information

• Brand Name: PREALBUMIN (PreALB)
• Primary DI: 05055273204759
• Version / Model: PA3843
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-05
• Public Version: 1
• Public Version Date: 2022-10-13
• Public Version Status: New
• Public Device Record Key: 3fd4a494-639b-4988-b815-a93b6dbe8867

Device Description

A prealbumin (transthyretin) test system is a device intended for the quantitative in vitro determination of prealbumin (transthyretin) concentration in serum.

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: 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	05055273204759	GS1

Customer Contacts

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

Storage Conditions

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