Seraquest Rubella Igg

• • Terminated Z-2201-2011 FDA Unclassified (pre-2012) ·initiated 19 Jul 2010

  The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.

• • Terminated Z-0908-2010 FDA Unclassified (pre-2012) ·initiated 20 Aug 2008

  Elevated optical density (OD) values with the kit Negative Control.

510(k) Number

K961053 ↗

FDA Product Code

LFX

Device Class

Class II

Regulation

21 CFR Part 866.3510

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Anti-Cardiolipin, Multiple Autoantibodies Immunological Test System

  Class II

  FDA 510(k) K003069 Active Cleared 27 Nov 2000

• Seraquest Eb Na Igg

  Class I

  FDA 510(k) K991975 Active Cleared 2 Nov 1999

• Seraquest Anti-Thyroglobulin

  Class II

  FDA 510(k) K023592 Active Cleared 6 Jan 2003

• Latex Examination Gloves Non-Sterile

  Class I

  FDA 510(k) K890356 Active Cleared 6 Apr 1989

• Seraquest Toxoplasma Igg

  Class II

  FDA 510(k) K960092 Active Cleared 17 Jun 1996

• Seraquest Vzv Igg

  Class II

  FDA 510(k) K972295 Active Cleared 5 Nov 1997

See all devices from Quest Intl., Inc. →