ImmunoCAP Antigen AGf98, Gliadin

Basic Information

• Brand Name: ImmunoCAP Antigen AGf98, Gliadin
• Primary DI: 07333066003757
• Version / Model: 14-4425-01
• Catalog Number: 14-4425-01
• Company Name: Phadia AB
• Labeler DUNS: 354019424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 83bd6513-40d1-4543-baa7-dead8f278842

Device Description

ImmunoCAP Antigen AGf98, Gliadin

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
MST	Antibodies, gliadin	Immunology	866.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54946	Gliadin antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-gliadin antibodies in a clinical specimen, using a fluorescent immunoassay method. This test is intended to be used as an aid in the diagnosis of Coeliac disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07333066003764	GS1		3	In Commercial Distribution
Primary	07333066003757	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K052793	000

Storage Conditions

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