Access Thyroglobulin C71762

GUDID 15099590754501

Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.

Beckman Coulter, Inc.

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• Primary Device ID: 15099590754501
• NIH Device Record Key: 4edfaf4c-52bd-4df9-8ac4-b82177b5b027
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Thyroglobulin
• Version Model Number: C71762
• Catalog Number: C71762
• 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	15099590754501 [Primary]

FDA Product Code

• MSW: System,Test,Thyroglobulin

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: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [Access Thyroglobulin]

• 15099590227173: The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the
• 15099590754501: Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quan