Directigen Neissena Menningitidis Group B Test

• 2 recalls, same reason

  • Terminated Z-1560-2008 FDA Unclassified (pre-2012) ·initiated 6 Sep 2007
  • Terminated Z-1559-2008 FDA Unclassified (pre-2012) ·initiated 6 Sep 2007

  Exhibits cross reactivity with Neisseria meningitides Group W135.

• 2 recalls, same reason

  • Terminated Z-1562-2008 FDA Unclassified (pre-2012) ·initiated 6 Sep 2007
  • Terminated Z-1561-2008 FDA Unclassified (pre-2012) ·initiated 6 Sep 2007

  Exhibits cross reactivity with Neisseria meningitides Group W135

510(k) Number

K844407 ↗

FDA Product Code

GTJ

Device Class

Class II

Regulation

21 CFR Part 866.3390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →