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 | ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | SIEMENS CORP. 511 Benedict Avenue Tarrytown, NY 10591 |
PMA Number | P110041 |
Supplement Number | S004 |
Date Received | 07/24/2017 |
Decision Date | 04/19/2018 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for migration of the ADVIA Centaur HBsAgII (HBsII), the ADVIA Centaur HBsAg Confirmatory, and the ADVIA Centaur HBsAg Quality Control Material onto the Atellica IM analyzer. |
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