NOP · Class II · 21 CFR 866.3940

FDA Product Code NOP: Elisa, Antibody, West Nile Virus

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.

Leading manufacturers include Panbio Limited, Focus Technologies, Inc. and Euroimmun Us, Inc..

10
Total
9
Cleared
172d
Avg days
2003
Since

FDA 510(k) Cleared Elisa, Antibody, West Nile Virus Devices (Product Code NOP)

10 devices
1–10 of 10
Cleared Aug 12, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
K153308
Euroimmun Us, Inc.
Microbiology · 269d
Cleared Aug 10, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
K153303
Euroimmun Us, Inc.
Microbiology · 268d
Cleared Nov 30, 2006
SPECTRAL WEST NILE VIRUS IGM STATUS TEST
K052519
Spectral Diagnostics, Inc.
Microbiology · 442d
Cleared Nov 19, 2004
WEST NILE DETECT IGM ELISA
K041817
Inbios Intl., Inc.
Microbiology · 136d
Cleared Oct 20, 2004
WEST NILE VIRUS IGG INDIRECT ELISA
K041068
Panbio Limited
Microbiology · 177d
Cleared Aug 10, 2004
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
K041231
Panbio Limited
Microbiology · 92d
Cleared Jun 30, 2004
WEST NILE VIRUS IGM CAPTURE ELISA
K040854
Focus Technologies, Inc.
Microbiology · 90d
Cleared Oct 22, 2003
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
K031952
Focus Technologies, Inc.
Microbiology · 119d
Cleared Oct 22, 2003
WEST NILE VIRUS ELISA IGG, MODEL EL0300G
K031953
Focus Technologies, Inc.
Microbiology · 119d
Not Cleared Jul 08, 2003
WEST NILE VIRUS IGM CAPTURE ELISA
DEN030004
Panbio Limited
Microbiology · 5d

About Product Code NOP - Regulatory Context