ImmunoCAP Total IgE

Basic Information

• Brand Name: ImmunoCAP Total IgE
• Primary DI: 07333066019673
• Version / Model: 10-9517-02
• Catalog Number: 10-9517-02
• Company Name: Phadia AB
• Labeler DUNS: 354019424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-26
• Public Version: 1
• Public Version Date: 2019-04-03
• Public Version Status: New
• Public Device Record Key: a20a4f2b-f7eb-44e4-8fcc-7af4c5d81ea5

Device Description

Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
DGC	IGE, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53776	Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) 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	07333066019673	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133404	000

Storage Conditions

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