FDA 510(k) Applications for Medical Device Product Code "NOP"
(Elisa, Antibody, West Nile Virus)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K153303 | EUROIMMUN US, INC. | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | 08/10/2016 |
| K153308 | EUROIMMUN US, INC. | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | 08/12/2016 |
| K031953 | FOCUS TECHNOLOGIES, INC. | WEST NILE VIRUS ELISA IGG, MODEL EL0300G | 10/22/2003 |
| K040854 | FOCUS TECHNOLOGIES, INC. | WEST NILE VIRUS IGM CAPTURE ELISA | 06/30/2004 |
| K031952 | FOCUS TECHNOLOGIES, INC. | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M | 10/22/2003 |
| K041817 | INBIOS INTL., INC. | WEST NILE DETECT IGM ELISA | 11/19/2004 |
| K041068 | PANBIO LIMITED | WEST NILE VIRUS IGG INDIRECT ELISA | 10/20/2004 |
| DEN030004 | PANBIO LIMITED | WEST NILE VIRUS IGM CAPTURE ELISA | 07/08/2003 |
| K041231 | PANBIO LIMITED | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M | 08/10/2004 |
| K052519 | SPECTRAL DIAGNOSTICS, INC. | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | 11/30/2006 |
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