IMMUNO CONCEPTS 8131

GUDID M7490081311

Custom - EBNA FA BP - 3900 wells

IMMUNO CONCEPTS INC

Multiple thyroid antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: M7490081311
• NIH Device Record Key: 15cd22f3-6e85-438a-83ac-dc05d6ced053
• Commercial Distribution Discontinuation: 2025-08-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IMMUNO CONCEPTS
• Version Model Number: 8131
• Catalog Number: 8131
• 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	M7490081311 [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: 2025-08-12
• Device Publish Date: 2016-09-24

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• M7490081311: Custom - EBNA FA BP - 3900 wells