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Vidas Estradiol II (E2II) Assay

by Biomerieux Vitek, Inc.

510(k) K955647

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK955647 Date6 Feb 1996ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0867-2023 FDA Class II initiated 9 Nov 2022

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

    • Terminated Z-1801-2017 FDA Class II initiated 17 Mar 2017

    Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.

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  • Withdrawn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
CHP
Device Class
Class I
Regulation
21 CFR Part 862.1260
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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