510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NOPClass II

Elisa, Antibody, West Nile Virus

21 CFR 866.3940 / Microbiology
FDA source (opens on fda.gov)

NOP is the FDA product code for Elisa, Antibody, West Nile Virus, a class II device type, regulated under 21 CFR 866.3940. FDA's definition for this code reads: "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". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NOP
Device name
Elisa, Antibody, West Nile Virus
FDA definition
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.
Regulation
21 CFR 866.3940
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
2

Clearances, product code NOP

By decision year
10 clearances under product code NOP with a decision year between 2003 and 2016, 2004 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NOP by decision year
YearClearances
20033
20044
20061
20162

Applicants with the most clearances

Product code NOP
Applicants holding the most 510(k) clearances under product code NOP
ApplicantClearances
Focus Technologies, Inc.3
Panbio Limited3
Euroimmun US Inc.2
Inbios Intl., Inc.1
Spectral Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code