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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 VERSANT®HIV-1 RNA 3.0 Assay (bDNA).
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Siemens Medical Solutions Diagnostics
p.o. box 2466
Berkeley , CA 94702 -0466
PMA NumberBP000028
Supplement NumberS031
Date Received08/13/2010
Decision Date10/22/2010
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement Type135 Day Track for 30 Day Notification
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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