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, Euroimmun Us, Inc. and Inbios Intl., 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 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

About Product Code NOP - Regulatory Context