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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS019
Date Received07/01/2009
Decision Date12/10/2009
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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