AutoDELFIA Neonatal Thyroxine (T4) kit

Basic Information

• Brand Name: AutoDELFIA Neonatal Thyroxine (T4) kit
• Primary DI: 06438147179602
• Version / Model: B065-01C
• Catalog Number: B065-01C
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0e501187-afc5-48cc-9d86-af8c38b6b2b3

Device Description

Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried blood.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
CDX	Radioimmunoassay, Total Thyroxine	Clinical Chemistry	862.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59222	Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal thyroxine (neonatal T4) in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147179602	GS1

Storage Conditions

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