Seraquest Cmv Igm

• • Ongoing Z-0342-2023 FDA Class II ·initiated 19 Oct 2022

  Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

• • Terminated Z-0837-2012 FDA Unclassified (pre-2012) ·initiated 28 Sep 2010 ·on shared 510(k) K982485

  Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K982485 ↗

FDA Product Code

LFZ

Device Class

Class II

Regulation

21 CFR Part 866.3175

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. →