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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.
 
DeviceADVIA CENTAUR AFP ASSAY
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSiemens Healthcare Diagnostics, Inc.
333 Coney St.
East Walpole, MA 02032
PMA NumberP930036
Supplement NumberS006
Date Received07/17/2015
Decision Date04/13/2018
Product Code LOK 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the migration of the ADVIA Centaur AFP assay to the ADVIA Centaur XPT system
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