Panels › Microbiology › Product code NOP · Class 2
Elisa, Antibody, West Nile Virus
Regulation 866.3940
0510(k)s in 12 months (10 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NOP
| Company | 510(k)s | Recalls |
|---|---|---|
| Focus Technologies, Inc. | 3 | 0 |
| Panbio Limited | 3 | 0 |
| Euroimmun Us, Inc. | 2 | 0 |
| Focus Diagnostics Inc | 0 | 1 |
| Inbios Intl., Inc. | 1 | 0 |
| Inverness Medical | 0 | 1 |
| Spectral Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 2016 | K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) Euroimmun Us, Inc. | NOP |
| Aug 10, 2016 | K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) Euroimmun Us, Inc. | NOP |
| Nov 30, 2006 | K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST Spectral Diagnostics, Inc., CA | NOP |
| Nov 19, 2004 | K041817 | WEST NILE DETECT IGM ELISA Inbios Intl., Inc. | NOP |
| Oct 20, 2004 | K041068 | WEST NILE VIRUS IGG INDIRECT ELISA Panbio Limited, AU | NOP |
| Aug 10, 2004 | K041231 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M Panbio Limited, AU | NOP |
| Jun 30, 2004 | K040854 | WEST NILE VIRUS IGM CAPTURE ELISA Focus Technologies, Inc. | NOP |
| Oct 22, 2003 | K031953 | WEST NILE VIRUS ELISA IGG, MODEL EL0300G Focus Technologies, Inc. | NOP |
| Oct 22, 2003 | K031952 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M Focus Technologies, Inc. | NOP |
| Jul 8, 2003 | DEN030004 | WEST NILE VIRUS IGM CAPTURE ELISA Panbio Limited, AU | NOP |
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