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T-Uptake EIA Test

by Diagnostic Reagents, Inc. 510(k)

Active United States

510(k) K951586

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951586 Date15 May 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
KHQ
Device Class
Class II
Regulation
21 CFR Part 862.1715
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The T-Uptake EIA Test is an enzyme immunoassay (EIA) device used for measuring triiodothyronine uptake (T3 uptake) in serum or plasma. It falls under the category of radioassay devices and is designed to evaluate thyroid function by assessing the binding capacity of thyroid hormone transport proteins. This diagnostic tool aids clinicians in diagnosing and monitoring thyroid-related disorders by providing quantitative results on hormone uptake levels.

This test is supplied as a single-use diagnostic reagent kit and is intended for use in clinical chemistry laboratories. It is classified as a Class II medical device under FDA regulation 862.1715 and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The kit requires standard laboratory equipment and procedures, with results interpreted based on manufacturer-provided standards and controls. No specific MRI safety considerations are noted, and sterility is ensured through appropriate packaging and handling protocols.

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