EUROIMMUN Anti-West Nile Virus ELISA (IgM)
FDA 510(k) K153308 · Euroimmun Us, Inc.
510(k) numberK153308
Submission
- Device name
- EUROIMMUN Anti-West Nile Virus ELISA (IgM)
- Applicant
- Euroimmun Us, Inc.
Morris Plains, NJ, US - Received
- November 17, 2015
- Decision date
- August 12, 2016
- 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG · Traditional | 09/17/2020SE |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue…MVM · Traditional | 02/28/2019SE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | 05/24/2018SE |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL · Traditional | 04/20/2018SE |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL · Traditional | 04/20/2018SE |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR · Traditional | 12/10/2017SE |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG)LSR · Traditional | 08/25/2016SE |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP · Traditional | 08/10/2016SE |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM)LSR · Traditional | 05/04/2015SE |
| K141827 | Euroimmun Ifa 40: HEP-20-10; Europattern Microscope and SoftwareDHN · Traditional | 04/17/2015SE |
Questions and answers
When was EUROIMMUN Anti-West Nile Virus ELISA (IgM) cleared by the FDA?
EUROIMMUN Anti-West Nile Virus ELISA (IgM) (K153308) received a 510(k) decision of Substantially Equivalent on August 12, 2016, 269 days after the submission was received.
What is the product code of K153308?
The FDA product code is NOP – Elisa, Antibody, West Nile Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3940.