Histofluor® IgG Fluorescent Antibody Test System 12009-10 (1)

GUDID M74912009101

Histofluor® IgG Fluorescent Antibody Reagent 1 x 9ml.

IMMUNO CONCEPTS INC

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

• Primary Device ID: M74912009101
• NIH Device Record Key: 9589aa63-860a-49d0-8de1-cb7d1e0f92d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histofluor® IgG Fluorescent Antibody Test System
• Version Model Number: 12009-10 (1)
• Catalog Number: 12009-10 (1)
• 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	M74912009101 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-06
• Device Publish Date: 2024-02-27

Devices Manufactured by IMMUNO CONCEPTS INC

• M7490081311 - IMMUNO CONCEPTS: 2025-08-12 Custom - EBNA FA BP - 3900 wells
• M7490083231 - Fluorescent ANA Test System: 2025-06-06 ANA Fluorescent w/cs Bulk Pack - 1400 Tests
• M749100420111 - ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests: 2025-06-06 ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests
• M7491014011T1 - ANCA Test System: 2025-06-06 ANCA FA Test System - Ethanol Fixed Substrate - 70 wells
• M7498318RO1 - HEp-2000® IgG Fluorescent ANA-Ro Test System: 2025-06-06 Custom - HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 1800 Tests
• M7498262RO1 - HEp-2000® Fluorescent ANA-Ro Test System: 2025-06-05 Custom - HEp-2000® FA ANA-Ro BP - 6300 wells
• M749120210211 - Histofluor® Rodent LKS Fluorescent Antibody Test System: 2025-06-03 AMA Positive Control 1 x 1.0 ml
• M74912400011 - Histofluor® Primate Esophagus Autoantibody Fluorescent Test System: 2025-06-03 Histofluor® Primate Esophagus Tissue BP FA Test System - 400 Tests