West Nile Virus Igm Capture Elisa

No FDA recalls found in the data synced 11 Oct 2026.

De Novo Number

DEN030004 ↗

FDA Product Code

NOP

Device Class

Class II

Regulation

21 CFR Part 866.3940

Advisory Committee

Microbiology

FDA Decision

DENG De Novo granted

• Tpp

  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

• 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

• West Nile Virus Igm Capture Elisa, Model E-WNV02M

  Class II

  FDA 510(k) K041231 Active Cleared 10 Aug 2004

• Fif Tm

  Class II

  FDA 510(k) K970189 Active Cleared 21 May 1997

See all devices from Panbio Limited →