Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12400-01

GUDID M74912400011

Histofluor® Primate Esophagus Tissue BP FA Test System - 400 Tests

IMMUNO CONCEPTS INC

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

• Primary Device ID: M74912400011
• NIH Device Record Key: 427d10d4-717e-4274-bb49-7a7b57c872dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histofluor® Primate Esophagus Autoantibody Fluorescent Test System
• Version Model Number: 12400-01
• Catalog Number: 12400-01
• Company DUNS: 038271904
• Company Name: IMMUNO CONCEPTS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M74912400011 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-03
• Device Publish Date: 2020-07-01

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