Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System

• • Terminated Z-2082-2011 FDA Unclassified (pre-2012) ·initiated 11 Mar 2011

  Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set Lot #46704.

• • Terminated Z-1157-2008 FDA Unclassified (pre-2012) ·initiated 13 Nov 2007

  False negative results due to reagent packs exhibiting low signal.

510(k) Number

K062211 ↗

FDA Product Code

LSE

Device Class

Class I

Regulation

21 CFR Part 866.3235

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Kallestad Rsv Microplate Eia

  Class I

  FDA 510(k) K924289 Active Cleared 12 Feb 1993

• Access(R) Total Ige Assay

  Class II

  FDA 510(k) K930984 Active Cleared 9 Jun 1993

• Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329

  Class II

  FDA 510(k) K963934 Active Cleared 16 Dec 1996

• Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200

  Class II

  FDA 510(k) K041658 Active Cleared 20 Dec 2004

• Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and Bi

  Class II

  FDA 510(k) K130053 Active Cleared 19 Sep 2013

• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

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