GSP Neonatal Thyroxine (T4) kit

Basic Information

• Brand Name: GSP Neonatal Thyroxine (T4) kit
• Primary DI: 06438147312139
• Version / Model: 3302-001U
• Catalog Number: 3302-001U
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 90d5b38f-380b-44bd-9305-a32052091956

Device Description

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
KLI	Enzyme Immunoassay, Non-Radiolabeled, 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	06438147312139	GS1

Premarket Submissions

Submission Number	Supplement Number
K103484	000

Storage Conditions

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