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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® 2000 HBsAg, IMMULITE® 2000 HBsAg Confirmatory
ApplicantSiemens Healthcare Diagnostics Products, Ltd.
Glyn Rhonwy
Llanberis LL55 4EL
PMA NumberP010050
Supplement NumberS020
Date Received03/21/2022
Decision Date08/30/2023
Reclassified Date10/20/2025
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate 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 change in labeling to include a limitation regarding interference from the drug STRENSIQ.
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