West Nile Virus Igm Capture Elisa, Model E-WNV02M
FDA 510(k) K041231 · Panbio Limited
510(k) numberK041231
Submission
- Device name
- West Nile Virus Igm Capture Elisa, Model E-WNV02M
- Applicant
- Panbio Limited
Windsor, AU - Received
- May 10, 2004
- Decision date
- August 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NOP – Elisa, Antibody, West Nile Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3940
- Specialty
- Microbiology
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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP · Traditional | Euroimmun Us, Inc. | 08/12/2016SE |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP · Traditional | Euroimmun Us, Inc. | 08/10/2016SE |
| K052519 | Spectral West Nile Virus Igm Status TestNOP · Traditional | Spectral Diagnostics, Inc. | 11/30/2006SE |
| K041817 | West Nile Detect Igm ElisaNOP · Traditional | Inbios Intl., Inc. | 11/19/2004SE |
| K041068 | West Nile Virus Igg Indirect ElisaNOP · Traditional | Panbio Limited | 10/20/2004SE |
| K040854 | West Nile Virus Igm Capture ElisaNOP · Traditional | Focus Technologies, Inc. | 06/30/2004SE |
| K031953 | West Nile Virus Elisa Igg, Model EL0300GNOP · Traditional | Focus Technologies, Inc. | 10/22/2003SE |
| K031952 | West Nile Virus Igm Capture Elisa, Model EL0300MNOP · Traditional | Focus Technologies, Inc. | 10/22/2003SE |
More from Focus Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K041068 | West Nile Virus Igg Indirect ElisaNOP · Traditional | 10/20/2004SE |
| K030863 | Ebv VCA-P18 Igg ElisaLSE · Traditional | 06/27/2003SE |
| K002024 | Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to…GRY · Traditional | 11/22/2000SE |
| K970189 | Fif TMKQJ · Traditional | 05/21/1997SE |
| K962176 | TPPMIF · Traditional | 10/18/1996SE |
| K910636 | Abs CadkitGIS · Traditional | 04/29/1991SE |
Questions and answers
When was West Nile Virus Igm Capture Elisa, Model E-WNV02M cleared by the FDA?
West Nile Virus Igm Capture Elisa, Model E-WNV02M (K041231) received a 510(k) decision of Substantially Equivalent on August 10, 2004, 92 days after the submission was received.
What is the product code of K041231?
The FDA product code is NOP – Elisa, Antibody, West Nile Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3940.