Cleared Traditional

WEST NILE VIRUS IGG INDIRECT ELISA

K041068 · Panbio Limited · Microbiology

Oct 2004

Decision

177d

Days

Class 2

Risk

About This 510(k) Submission

K041068 is an FDA 510(k) clearance for the WEST NILE VIRUS IGG INDIRECT ELISA, a Elisa, Antibody, West Nile Virus (Class II — Special Controls, product code NOP), submitted by Panbio Limited (Windsor, AU). The FDA issued a Cleared decision on October 20, 2004, 177 days after receiving the submission on April 26, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3940.

Submission Details

510(k) Number	K041068 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2004
Decision Date	October 20, 2004
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	NOP — Elisa, Antibody, West Nile Virus
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3940
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.