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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.
 
DeviceIMMULITE Systems AFP
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSiemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP010007
Supplement NumberS027
Date Received07/23/2026
Decision Date08/20/2026
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  
Approval of the change to the bead drying process used in the manufacture of bead components for the IMMULITE 2000 AFP, Free PSA, and PSA assays.
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