Access Thyroglobulin Antibody II C86552

GUDID 15099590763527

The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.

Beckman Coulter, Inc.

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 15099590763527
• NIH Device Record Key: 43f74e51-ede4-4908-babc-a9bf4c97cdd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Thyroglobulin Antibody II
• Version Model Number: C86552
• Catalog Number: C86552
• 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	15099590763527 [Primary]

FDA Product Code

• JZO: System, Test, Thyroid Autoantibody

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 Antibody II]

• 15099590202910: The Access Thyroglobulin Antibody II (TgAb) assay is a paramagnetic particle, chemiluminescent i
• 15099590763527: The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoas