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Vitek Immunodiagnostic Assay System

by Biomerieux Vitek, Inc.

510(k) K923122

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923122 Date26 Oct 1992ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0795-2023 FDA Class II initiated 9 Nov 2022

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

    • Terminated Z-1107-2020 FDA Class II initiated 10 Dec 2019

    Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.

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  • Withdrawn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
LFY
Device Class
Class II
Regulation
21 CFR Part 866.3900
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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