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Anti-Thyroglobulin (tg) Microplate Elisa

FDA 510(k)

Class II (US FDA 510(k))

510(k) K971835

by Monobind, Inc.

Identifiers

510(k) Number
K971835 FDA 510(k)
FDA Product Code
DDC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5870 FDA 510(k)
Regulation Number
866.5870 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an anti-thyroglobulin (TG) microplate ELISA test system designed for the detection of autoantibodies to thyroglobulin in human serum. It utilizes ELISA technology based on the streptavidin-biotin reaction, where biotinylated thyroglobulin antigen is used to form immune complexes with anti-TG antibodies present in the specimen.

The test is performed by adding serum reference, diluted patient specimen, or control to a microplate well, followed by the addition of biotinylated thyroglobulin and mixing of reactants. It is supplied as a kit for in vitro diagnostic use in clinical laboratory settings. The device has received FDA 510(k) clearance (K971835) and is classified as a Class II medical device under regulation number 866.5870 with product code DDC.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA by MONOBIND | FDA 510 (k) Summary, Thyroglobulin Ab (Anti-Tg) Test System Product Code: 1025-300, Thyroglobulin (Tg) Test System - monobind.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monobind, Inc.
FDA Applicant
Monobind

Sources (1)

  • FDA 510(k) K971835 24 fields · synced Sep 24, 2026