WEST NILE VIRUS IGM CAPTURE ELISA


Device Classification Name

elisa, antibody, west nile virus

510(k) Number DEN030004
Device Name WEST NILE VIRUS IGM CAPTURE ELISA
Original Applicant
PANBIO LIMITED
116 lutwyche rd.
windsor, brisbane, 

AU

4030

Original Contact helen jennings
Regulation Number 866.3940
Classification Product Code
NOP  
Date Received 07/03/2003
Decision Date 07/08/2003
Decision

an

(AN)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Post-NSE

Reviewed by Third Party No

Combination Product

No