Histofluor® Primate Esophagus Autoantibody Fluorescent Test System

Basic Information

• Brand Name: Histofluor® Primate Esophagus Autoantibody Fluorescent Test System
• Primary DI: M7491208001RT1
• Version / Model: 12080-01R (T)
• Catalog Number: 12080-01R (T)
• Company Name: IMMUNO CONCEPTS INC
• Labeler DUNS: 038271904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-03
• Public Version: 1
• Public Version Date: 2025-06-11
• Public Version Status: New
• Public Device Record Key: 6c131c39-e7c2-4b77-82d5-98c1564ffe13

Device Description

Histofluor(R) Anti-Endomysial Autoantibody FA Test System - 40 Tests

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
54905	Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7491208001RT1	HIBCC