Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12040-01

GUDID M74912040011

Primate Esophagus Tissue FA Test System - 40 tests

IMMUNO CONCEPTS INC

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

• Primary Device ID: M74912040011
• NIH Device Record Key: a14a89a8-d42d-4aaf-9c7b-54c1e448bb1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histofluor® Primate Esophagus Autoantibody Fluorescent Test System
• Version Model Number: 12040-01
• Catalog Number: 12040-01
• 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	M74912040011 [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: 3
• Public Version Date: 2019-11-14
• Device Publish Date: 2016-09-24

On-Brand Devices [Histofluor® Primate Esophagus Autoantibody Fluorescent Test System ]

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• M74912160011: Primate Esophagus Tissue FA Test System - 160 tests
• M7491200401101: Primate Esophagus 4 Well Tissue Slides - 10 Slides
• M74912040011: Primate Esophagus Tissue FA Test System - 40 tests
• M7491200801101: Primate Esophagus 8 Well Tissue Slides - 10 Slides