Elisa, Antibody, West Nile Virus
Microbiology · 21 CFR 866.3940
The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.
Recent MDR events
5 adverse event reports on file
- PROCLEIX WEST NILE VIRUS ASSAYNov 27, 2019DeathGrifols Diagnostics Solutions Inc.2032600-2019-00011
- WEST NILE IGM EIAOct 10, 2014InjuryFocus DiafnosticsMW5038631
- COBAS TAQSCREEN WNV (WEST NILE VIRUS) TESTSep 5, 2013DeathRoche Molecular Systems2243471-2013-00026
- WEST NILE VIRUS ASSAYFeb 6, 2007InjuryNot IdentifiedMW1041853
- PROCLEIX WEST NILE VIRUS ASSAYMar 25, 2005Gen-probe593761
Event type breakdown
Recalls
2 recall events for this product code
- Focus Diagnostics IncTerminatedOct 31, 2012
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Z-0182-2013 · View FDA record ↗ - Inverness MedicalTerminatedFeb 14, 2012
West Nile Virus IgM Capture ELISA
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
Z-1014-2012 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Diasorin Molecular Llc
CYPRESS, CA, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Inbios International, Inc.
Seattle, WA, US
Drg International, Inc.
Springfield, NJ, US
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Drg Instruments Gmbh
MARBURG Hesse, DE
510(k) clearances
10 clearances for this product code
- Euroimmun Us, Inc.Aug 12, 2016
K153308 · EUROIMMUN Anti-West Nile Virus ELISA (IgM)
- Euroimmun Us, Inc.Aug 10, 2016
K153303 · EUROIMMUN Anti-West Nile Virus ELISA (IgG)
- Spectral Diagnostics, Inc.Nov 30, 2006
K052519 · SPECTRAL WEST NILE VIRUS IGM STATUS TEST
- Inbios Intl., Inc.Nov 19, 2004
K041817 · WEST NILE DETECT IGM ELISA
- Panbio LimitedOct 20, 2004
K041068 · WEST NILE VIRUS IGG INDIRECT ELISA
- Panbio LimitedAug 10, 2004
K041231 · WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
- Focus Technologies, Inc.Jun 30, 2004
K040854 · WEST NILE VIRUS IGM CAPTURE ELISA
- Focus Technologies, Inc.Oct 22, 2003
K031952 · WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M