West Nile Virus Igm Capture Elisa, Model E-WNV02M

• • Terminated Z-1014-2012 FDA Unclassified (pre-2012) ·initiated 8 Oct 2008

  It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots. Internal quality assurance testing has shown that the products are performing within the release specifications, although there has been a slight shift in the cut-off which may lead to an increase in the number of positive results obta

510(k) Number

K041231 ↗

FDA Product Code

NOP

Device Class

Class II

Regulation

21 CFR Part 866.3940

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K962176 Active Cleared 18 Oct 1996

• Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to Leptospira Biflexa

  Class II

  FDA 510(k) K002024 Active Cleared 22 Nov 2000

• West Nile Virus Igm Capture Elisa

  Class II

  FDA De Novo DEN030004 Active Cleared 8 Jul 2003 FDA 510(k)

• Abs Cadkit

  Class II

  FDA 510(k) K910636 Active Cleared 29 Apr 1991

• Ebv Vca-P18 Igg Elisa

  Class I

  FDA 510(k) K030863 Active Cleared 27 Jun 2003

• Fif Tm

  Class II

  FDA 510(k) K970189 Active Cleared 21 May 1997

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