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 | Atellica IM Hepatitis B core Antigen (aHBcM) |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P030040 |
Supplement Number | S012 |
Date Received | 06/16/2017 |
Decision Date | 05/03/2018 |
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 the migration of the ADVIA Centaur HBc IgM (aHBcM) assay to the Atellica IM Analyzer. |
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