West Nile Virus Igm Capture Elisa, Model EL0300M
FDA 510(k) K031952 · Focus Technologies, Inc.
510(k) numberK031952
Submission
- Device name
- West Nile Virus Igm Capture Elisa, Model EL0300M
- Applicant
- Focus Technologies, Inc.
Cypress, CA, US - Received
- June 25, 2003
- Decision date
- October 22, 2003
- 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.
Other 510(k)s with product code NOP
| 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 |
| K041231 | West Nile Virus Igm Capture Elisa, Model E-WNV02MNOP · Traditional | Panbio Limited | 08/10/2004SE |
| 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 |
More from Focus Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040854 | West Nile Virus Igm Capture ElisaNOP · Traditional | 06/30/2004SE |
| K031953 | West Nile Virus Elisa Igg, Model EL0300GNOP · Traditional | 10/22/2003SE |
| K021486 | Herpeselect 2 Elisa Igg, Model ELO920GMXJ · Traditional | 08/01/2002SE |
| K021429 | Herpeselect 1 Elisa Igg, Model EL0910GMXJ · Traditional | 07/29/2002SE |
Questions and answers
When was West Nile Virus Igm Capture Elisa, Model EL0300M cleared by the FDA?
West Nile Virus Igm Capture Elisa, Model EL0300M (K031952) received a 510(k) decision of Substantially Equivalent on October 22, 2003, 119 days after the submission was received.
What is the product code of K031952?
The FDA product code is NOP – Elisa, Antibody, West Nile Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3940.