Panels › Microbiology › Product code NOP · Class 2
Elisa, Antibody, West Nile Virus
Regulation 866.3940
0510(k)s in 12 months (10 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NOP
| Company | 510(k)s | Recalls |
|---|---|---|
| Focus Technologies, Inc. | 3 | 0 |
| Panbio Limited | 3 | 0 |
| Euroimmun Us, Inc. | 2 | 0 |
| Focus Diagnostics Inc | 0 | 1 |
| Inbios Intl., Inc. | 1 | 0 |
| Inverness Medical | 0 | 1 |
| Spectral Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2012 | Focus Diagnostics Inc West Nile Virus IgG DxSelect" kit Catalog No. EL0300G
Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen
Wells, Catalog Number EL0351, Lot Number 121117.
510 Terminated |
NOP | K031953 |
| Feb 14, 2012 | Inverness Medical West Nile Virus IgM Capture ELISA
The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical lab Terminated |
NOP | K041231 |
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