Hytec Specific/Total IgE Control

Basic Information

• Brand Name: Hytec Specific/Total IgE Control
• Primary DI: 00816879022285
• Version / Model: 74120
• Company Name: HYCOR BIOMEDICAL LLC
• Labeler DUNS: 010558476
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 6
• Public Version Date: 2024-09-06
• Public Version Status: Update
• Public Device Record Key: fc442291-fc7f-40b3-9bb9-25f85241daa4
• Distribution End Date: 2023-09-30

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
37763	Total immunoglobulin E (IgE total) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen.	No	Active
41349	Allergen-specific immunoglobulin E (IgE) antibody IVD, control	A material which is used to verify the performance of an assay intended to be 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	00816879022285	GS1

Customer Contacts

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