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125-I TSH Receptor Antibody Kit

by Cronus 510(k)

Active United States

510(k) K863006

Overview

This device is a System, Test, Thyroid Autoantibody, used for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum. It is an in vitro diagnostic test that utilizes a radioimmunoassay format to detect TSH receptor antibodies.

The kit is supplied with calibrators and is intended for use in immunology laboratory settings. It is a Class II device cleared under FDA 510(k) submission K863006, with product code JZO and regulation number 866.5870. The device is manufactured by Cronus and is not indicated as sterile, single-use, reusable, or MRI safe in the provided data.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863006 Date8 Sep 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JZO
Device Class
Class II
Regulation
21 CFR Part 866.5870
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Other devices from Cronus

Questions

  • What is the 125-I TSH Receptor Antibody Kit used for?

    The kit is used for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum, aiding in the assessment of thyroid autoantibodies in immunology laboratory settings.

  • How is the 125-I TSH Receptor Antibody Kit supplied and what does it include?

    The kit is supplied with calibrators and is intended for use in immunology laboratory settings as an in vitro diagnostic test utilizing a radioimmunoassay format.

  • Is the 125-I TSH Receptor Antibody Kit sterile, single-use, or reusable?

    The provided data does not indicate whether the device is sterile, single-use, or reusable; no such specifications are included in the device description or specifications.