Vidas Cmv Igm Assay

• • Terminated Z-0742-2022 FDA Class II ·initiated 9 Feb 2022

  Invalid calibrations (out of range high) while using the product.

• • Terminated Z-1408-2021 FDA Class II ·initiated 16 Mar 2021

  bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01).

510(k) Number

K933549 ↗

FDA Product Code

LKQ

Device Class

Class II

Regulation

21 CFR Part 866.3175

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Vitek Immun Assay Sys(Vidas) Thyroi Stim Hor Assay

  Class II

  FDA 510(k) K921816 Active Cleared 18 Jun 1992

• Hemolab

  Class II

  FDA 510(k) K931992 Active Cleared 22 Dec 1994

• Vidas Creatine Kinase Mb Assay 30-421

  Class II

  FDA 510(k) K962549 Active Cleared 30 Aug 1996

• Vidas Rotavirus (Rtv) Assay

  Class I

  FDA 510(k) K972895 Active Cleared 3 Oct 1997

• Hemolab Silimat Reagent

  Class I

  FDA 510(k) K920001 Active Cleared 25 Sep 1992

• Vidas T Uptake

  Class II

  FDA 510(k) K935816 Active Cleared 22 Mar 1994

See all devices from Biomerieux Vitek, Inc. →