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Vidas Thyroxine (T4) Assay (T4)

by Biomerieux Vitek, Inc.

510(k) K926393

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926393 Date13 May 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KLI
Device Class
Class II
Regulation
21 CFR Part 862.1700
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 VIDAS THYROXINE (T4) ASSAY (T4) is an enzyme immunoassay, non-radiolabeled, total thyroxine test. It is classified under Clinical Chemistry and is substantially equivalent to a predicate device under FDA 510(k) clearance.

The assay is intended for use on instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay for the determination of human thyroxine (T4) concentration in serum or plasma (heparin). It is supplied as a diagnostic aid in the diagnosis and treatment of thyroid disorders.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the VIDAS THYROXINE (T4) ASSAY (T4) used for?

    The VIDAS THYROXINE (T4) ASSAY (T4) is intended as a diagnostic aid in the diagnosis and treatment of thyroid disorders by quantitatively determining human thyroxine (T4) concentration in serum or plasma (heparin) using an automated enzyme-linked fluorescent immunoassay on VIDAS family instruments.

  • How is the VIDAS THYROXINE (T4) ASSAY (T4) supplied and what type of test is it?

    The assay is supplied as an enzyme immunoassay, non-radiolabeled, total thyroxine test in a format designed for use on instruments of the VIDAS family, providing automated quantitative measurement of T4 levels in clinical specimens.

  • What specimen types are compatible with the VIDAS THYROXINE (T4) ASSAY (T4)?

    The assay is designed for use with human serum or plasma (heparin) specimens, as specified in its intended use for the determination of thyroxine (T4) concentration in these sample types on VIDAS family instruments.