IFE IgE Antiserum

Basic Information

• Brand Name: IFE IgE Antiserum
• Primary DI: M52594200
• Version / Model: 9420
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 079396131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-27
• Public Version: 1
• Public Version Date: 2024-10-07
• Public Version Status: New
• Public Device Record Key: 2262e742-a825-4054-b44f-cf6d86c96ad4

Device Characteristics

• Single Use: Yes
• 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
CZJ	IGD, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53782	Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M52594200	HIBCC

Customer Contacts

• Phone: [phone] ext. 1600
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K872834	000