AutoDELFIA hAFP Kit

Basic Information

• Brand Name: AutoDELFIA hAFP Kit
• Primary DI: 06438147321315
• Version / Model: B079-201
• Catalog Number: B079-201
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 5
• Public Version Date: 2020-11-25
• Public Version Status: Update
• Public Device Record Key: 274039f8-e811-4900-85c7-1fb653256ce3
• Distribution End Date: 2020-10-04

Device Description

Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP)

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
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
54060	Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) 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	06438147321315	GS1

Premarket Submissions

Submission Number	Supplement Number
P970037	000
P970037	009
P970037	010
P970037	011

Storage Conditions

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