DELFIA hFSH kit

Basic Information

• Brand Name: DELFIA hFSH kit
• Primary DI: 06438147009183
• Version / Model: A017-201
• Catalog Number: A017-201
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-11
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 69fa7539-62bd-4fac-ade1-03689a1704a4
• Distribution End Date: 2016-11-04

Device Description

Time-resolved fluoroimmunoassay for the quantitative determination of human follicle stimulating hormone (hFSH).

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
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	862.1300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54186	Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147009183	GS1

Storage Conditions

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