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. |
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Device | IMMULITE® 2000 Anti-HBs |
Applicant | Siemens Healthcare Diagnostics Products, LTD GLYN RHONWY LLANBERIS, CAERNARFON LL55 |
PMA Number | P010052 |
Supplement Number | S015 |
Date Received | 03/21/2022 |
Decision Date | 08/30/2023 |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the change in labeling to include a limitation regarding interference from the drug STRENSIQ. |
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