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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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New Search Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device record is a supplement.
 
Device HIV-1 NucliSens QT
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
BioMerieux, Inc.
100 akzo avenue
Durham , NC 27712 
  
PMA NumberBP010001
Supplement NumberS010
Date Received10/11/2005
Decision Date10/28/2005
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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