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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantOrtho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101
PMA NumberP010021
Supplement NumberS013
Date Received03/20/2008
Decision Date04/16/2008
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE MODIFICATION TO INTERFACE THE AUTOMATED VITROS ANALYZER USING THE ROBOTIC INTERFACE MODULE (RIM) TO ENABLE AUTOMATIC TRAY LOADING BETWEEN THE VITROS ANALYZER AND ENGEN SYSTEM.
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