Mumps Igg Elisa Test System

• • Terminated Z-2573-2018 FDA Class III ·initiated 5 Jan 2018

  Contains a gel-like contaminant that may affect product performance.

• • Terminated Z-1685-2016 FDA Class II ·initiated 20 Oct 2014

  A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

• • Terminated Z-0557-06 FDA Unclassified (pre-2012) ·initiated 8 Aug 2005

  Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.

510(k) Number

K991274 ↗

FDA Product Code

LJY

Device Class

Class I

Regulation

21 CFR Part 866.3380

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K984228 Active Cleared 2 Feb 1999

• Is Borrelia Burgdorferi Igm Test System

  Class II

  FDA 510(k) K983606 Active Cleared 16 Dec 1998

• Anthos Phacts Version Microplate Reader

  Class I

  FDA 510(k) K962113 Active Cleared 5 Nov 1996

• Is-Anti-PR3 Igg Elisa Test System

  Class II

  FDA 510(k) K983740 Active Cleared 18 Nov 1998

• Vca Igm Elisa Test System

  Class I

  FDA 510(k) K982352 Active Cleared 25 Nov 1998

• Is-Anti-Mpo Igg Elisa Test System

  Class II

  FDA 510(k) K983390 Active Cleared 18 Nov 1998

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