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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 (XP/XPT, CP) AFP; Atellica IM AFP
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSiemens Healthcare Diagnostics, Inc.
333 Coney St.
East Walpole, MA 02032
PMA NumberP930036
Supplement NumberS020
Date Received09/01/2022
Decision Date09/30/2022
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Manufacturing process change to the affinity purification method used to purify the anti-AFP polyclonal antibodies (Lite Reagent).
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