Histofluor® IgA Fluorescent Antibody Test System 12021-01 (1)

GUDID M749120210111

Histofluor® EMA Positive Control 1 x 1.0 ml

IMMUNO CONCEPTS INC

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

• Primary Device ID: M749120210111
• NIH Device Record Key: fb168542-0084-4a29-b05c-991a5b1fd4f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histofluor® IgA Fluorescent Antibody Test System
• Version Model Number: 12021-01 (1)
• Catalog Number: 12021-01 (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	M749120210111 [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: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [Histofluor® IgA Fluorescent Antibody Test System ]

• M749120090111: Histofluor® IgA Fluorescent Antibody Reagent 1 x 9ml.
• M749120210111: Histofluor® EMA Positive Control 1 x 1.0 ml