Access Total T4 II C69047

GUDID 15099590754488

The Access Total T4 II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 is used, along with other laboratory tests, as an aid in the diagnosis and management of thyroid dysfunction.

Beckman Coulter, Inc.

Thyroxine binding capacity IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590754488
• NIH Device Record Key: a9533703-dba4-40de-9994-1e9c319d1290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Total T4 II
• Version Model Number: C69047
• Catalog Number: C69047
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590754488 [Primary]

FDA Product Code

• KLI: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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: 2025-09-29
• Device Publish Date: 2025-09-19

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