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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.
 
DeviceAtellica IM Alpha Fetoprotein (AFP)
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
333 CONEY STREET
EAST WALPOLE, MA 02032
PMA NumberP930036
Supplement NumberS021
Date Received08/14/2023
Decision Date02/08/2024
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
Approval Order Statement  
migration of the ADVIA Centaur AFP assay to the Atellica CI Analyzer
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