Light Diagnostics Simulfluor Flu a/Flu B

• 2 recalls, same reason

  • Terminated Z-0953-2009 FDA Unclassified (pre-2012) ·initiated 24 Nov 2008
  • Terminated Z-0954-2009 FDA Unclassified (pre-2012) ·initiated 24 Nov 2008

  Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.

510(k) Number

K974302 ↗

FDA Product Code

GNW

Device Class

Class I

Regulation

21 CFR Part 866.3330

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Coxsackievirus B3 Monoclonal Antibody

  Class I

  FDA 510(k) K936251 Active Cleared 8 Sep 1995

• Light Diagnostics Rabies Dfa Reagent

  Class II

  FDA 510(k) K972975 Active Cleared 22 Dec 1998

• Anti-Nuclear Antibody (Ana) Test Kit W/Rat Liver

  Class II

  FDA 510(k) K944192 Active Cleared 6 Mar 1995

• Coxsackievirus B4 Monoclonal Antibody

  Class I

  FDA 510(k) K936253 Active Cleared 8 Sep 1995

• Poliovirus 2 Monoclonal Antibody

  Class I

  FDA 510(k) K940034 Active Cleared 12 Sep 1995

• Enterovirus 70 Monclonal Antibody

  Class I

  FDA 510(k) K940363 Active Cleared 8 Sep 1995

See all devices from Light Diagnostics →