Thyroid Binding Globulin

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K772183 ↗

FDA Product Code

CEE

Device Class

Class II

Regulation

21 CFR Part 862.1685

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Thyroid Binding Globulin test system used for?

  The Thyroid Binding Globulin test system is used to measure thyroxine-binding globulin (TBG) levels in serum and plasma. This measurement aids in the diagnosis and treatment of thyroid diseases by assessing how much thyroxine is bound to this plasma protein.

• How is the Thyroid Binding Globulin test supplied?

  The Thyroid Binding Globulin test system is supplied as a Radioimmunoassay for Thyroxine-Binding Globulin, classified under product code CEE. It is intended for clinical chemistry laboratory use and requires appropriate laboratory facilities and trained personnel to perform the test accurately.

• What is the regulatory status of the Thyroid Binding Globulin test system?

  The Thyroid Binding Globulin test system is a Class II device that received FDA 510(k) clearance on December 20, 1977, as substantially equivalent. It is regulated under number 862.1685 and manufactured by Corning Medical & Scientific for clinical chemistry laboratory applications.

• Is the Thyroid Binding Globulin test system reusable or single-use?

  The Thyroid Binding Globulin test system is designed for laboratory use with patient samples. While the test system itself may contain components that are used for multiple tests, each patient sample should be processed individually according to the manufacturer's instructions to ensure accurate results and prevent cross-contamination.