Home › Device types › NOP
Elisa, Antibody, West Nile Virus
FDA product code NOP · Class 2 · Microbiology
17
Registered devices
5
Adverse events
2
Recalls
10
510(k) clearances
Devices with this code
West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control — DIASORIN MOLECULAR LLCWest Nile Virus DxSelect™ Negative Control — DIASORIN MOLECULAR LLCWest Nile Virus IgG DxSelect™ - IgG Conjugate — DIASORIN MOLECULAR LLCIgM Capture Wells — DIASORIN MOLECULAR LLCAnti-West Nile Virus ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGAnti-West Nile Virus ELISA (IgM) — EUROIMMUN Medizinische Labordiagnostika AGWest Nile Virus IgG DxSelect™ - IgG Antigen Wells — DIASORIN MOLECULAR LLCWest Nile Virus IgG DxSelect™ — DIASORIN MOLECULAR LLCWest Nile Virus IgG DxSelect™ IgG Cutoff Calibrator — DIASORIN MOLECULAR LLCWest Nile Virus IgM Capture DxSelect™ Positive Control — DIASORIN MOLECULAR LLCWest Nile Virus IgM Capture DxSelect™ Antigen — DIASORIN MOLECULAR LLCWest Nile Virus IgM Capture DxSelect™ — DIASORIN MOLECULAR LLCWest Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL) — DIASORIN MOLECULAR LLCWest Nile Detect IgM Capture ELISA — INBIOS INTERNATIONAL, INCWest Nile Virus IgM Capture DxSelect™ — DIASORIN MOLECULAR LLCWest Nile Virus IgM Capture DxSelect™ Anti-Flavivirus Conjugate — DIASORIN MOLECULAR LLCWest Nile Virus IgG DxSelect™ — DIASORIN MOLECULAR LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-10-03 | Focus Diagnostics Inc | The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate. |
| 2008-10-08 | Inverness Medical | It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lo |
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