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 Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control ( |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 BENEDICT AVE. TARRYTOWN, NY 10591 |
PMA Number | P100039 |
Supplement Number | S005 |
Date Received | 07/14/2017 |
Decision Date | 05/23/2018 |
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 Aproval for the migration of the ADVIA Centaur Anti-HBs2 (aHBs2) assay to the Atellica IM Analyzer. |
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