NOP
10 FDA 510(k) clearances · Product code
136 daysmedian time to decision
442 days90th percentile
10clearances measured
FDA profile
- Official device name
- Elisa, Antibody, West Nile Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3940
- Medical specialty
- Microbiology
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| EUROIMMUN Anti-West Nile Virus ELISA (IgM) (K153308) | Euroimmun Us, Inc. | 2016-08-12 |
| EUROIMMUN Anti-West Nile Virus ELISA (IgG) (K153303) | Euroimmun Us, Inc. | 2016-08-10 |
| SPECTRAL WEST NILE VIRUS IGM STATUS TEST (K052519) | Spectral Diagnostics, Inc. | 2006-11-30 |
| WEST NILE DETECT IGM ELISA (K041817) | Inbios Intl., Inc. | 2004-11-19 |
| WEST NILE VIRUS IGG INDIRECT ELISA (K041068) | Panbio Limited | 2004-10-20 |
| WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (K041231) | Panbio Limited | 2004-08-10 |
| WEST NILE VIRUS IGM CAPTURE ELISA (K040854) | Focus Technologies, Inc. | 2004-06-30 |
| WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (K031952) | Focus Technologies, Inc. | 2003-10-22 |
| WEST NILE VIRUS ELISA IGG, MODEL EL0300G (K031953) | Focus Technologies, Inc. | 2003-10-22 |
| WEST NILE VIRUS IGM CAPTURE ELISA (DEN030004) | Panbio Limited | 2003-07-08 |
Track NOP automatically
Every clearance here is in the API, with alerts when new ones post.