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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator; VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Ortho-Clinical Diagnostics, Inc.
100 indigo creek drive
Rochester , NY 14626 -5101
PMA NumberBP050051
Date Received09/12/2005
Decision Date03/27/2008
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S004 S005 S009 S010 S011 S012 S013 S014 S015 
S016 S017 S018 S019 S021 S023 S024 S025 S026 
S027 S029 S030 S031 S035 S036 S039 S040 S042 
S044 S045 S047 S048 S049 
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