Access Total T4 II Calibrators C69048

GUDID 15099590754495

The Access Total T4 II Calibrators are intended to calibrate the Access Total T4 II assay for the quantitative determination of thyroxine levels in human serum and plasma using the automated Access Immunoassay Systems.

Beckman Coulter, Inc.

Thyroxine binding capacity IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590754495
• NIH Device Record Key: 51e463a5-65f2-4a72-b168-16b77896218d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Total T4 II Calibrators
• Version Model Number: C69048
• Catalog Number: C69048
• 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	15099590754495 [Primary]

FDA Product Code

• JIS: Calibrator, 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: 2025-09-29
• Device Publish Date: 2025-09-19

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