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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name elisa, antibody, west nile virus
De Novo Number DEN030004
510(K) Number K031703
Device Name WEST NILE VIRUS IGM CAPTURE ELISA
Requester
panbio limited
116 lutwyche rd.
windsor, brisbane,  AU 4030
Contact helen jennings
Regulation Number866.3940
Classification Product Code
NOP  
Date Received07/03/2003
Decision Date 07/08/2003
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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