T-POC TOTAL IgE IMMUNOASSAY KIT

Basic Information

• Brand Name: T-POC TOTAL IgE IMMUNOASSAY KIT
• Primary DI: 00860009215139
• Version / Model: CP0001
• Catalog Number: CP0001
• Company Name: Axim Biotechnologies, Inc.
• Labeler DUNS: 079498248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-27
• Public Version: 1
• Public Version Date: 2024-04-04
• Public Version Status: New
• Public Device Record Key: a49552fe-1cba-40c9-a757-bfcc913d4b56

Device Description

LFIA kit for detection of IgE level in tear fluid.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
65992	Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment, typically to screen for allergies associated with certain conditions (e.g., food intolerance).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009215139	GS1