Elisa, Antibody, West Nile Virus
The West Nile Virus ELISA antibody test is a microbiology diagnostic device intended for the detection of IgG and IgM antibodies to West Nile Virus in serum or cerebrospinal fluid from symptomatic patients. It is classified as FDA Class 2 under regulation 866.3940 in the Microbiology specialty, requiring 510(k) premarket notification to demonstrate substantial equivalence. Product code NOP is not eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NOP
- Device Class
- FDA class 2
- Regulation Number
- 866.3940
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Aug 12, 2016 | Substantially Equivalent | Euroimmun Us, Inc. |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | Aug 10, 2016 | Substantially Equivalent | Euroimmun Us, Inc. |
| K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | Nov 30, 2006 | Substantially Equivalent | Spectral Diagnostics, Inc. |
| K041817 | WEST NILE DETECT IGM ELISA | Nov 19, 2004 | Substantially Equivalent | Inbios Intl., Inc. |
| K041068 | WEST NILE VIRUS IGG INDIRECT ELISA | Oct 20, 2004 | Substantially Equivalent | Panbio Limited |
| K041231 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M | Aug 10, 2004 | Substantially Equivalent | Panbio Limited |
| K040854 | WEST NILE VIRUS IGM CAPTURE ELISA | Jun 30, 2004 | Substantially Equivalent | Focus Technologies, Inc. |
| K031953 | WEST NILE VIRUS ELISA IGG, MODEL EL0300G | Oct 22, 2003 | Substantially Equivalent | Focus Technologies, Inc. |
| K031952 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M | Oct 22, 2003 | Substantially Equivalent | Focus Technologies, Inc. |
| DEN030004 | WEST NILE VIRUS IGM CAPTURE ELISA | Jul 08, 2003 | Unknown | Panbio Limited |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.