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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 Immunodiagnostic Products HIV Combo Calibrator; VITROS Immunodiagnostic Products HIV Combo 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 NumberBP160122
Supplement NumberS011
Date Received04/03/2019
Decision Date04/29/2019
Decision 30-Day Notice - No 135-Day Supplement Needed
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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