ImmunoCAP Gliadin IgA/IgG Control Low

Basic Information

• Brand Name: ImmunoCAP Gliadin IgA/IgG Control Low
• Primary DI: 07333066019901
• Version / Model: 34-2332-41
• Catalog Number: 34-2332-41
• Company Name: Phadia AB
• Labeler DUNS: 354019424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 1
• Public Version Date: 2019-04-08
• Public Version Status: New
• Public Device Record Key: 9cb88eab-b587-414c-8db8-23b5e540c6b3

Device Description

ImmunoCAP Gliadin IgA/IgG Control Low

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
30506	Plasma protein IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07333066000701	GS1		6	In Commercial Distribution
Primary	07333066019901	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