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 | Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ROCHE DIAGNOSTICS, INC. 9115 HAGUE ROAD INDIANAPOLIS, IN 46038 |
PMA Number | P160019 |
Supplement Number | S003 |
Date Received | 07/28/2017 |
Decision Date | 01/18/2018 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for migration of the Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II onto the cobas e 411 immunoassay analyzer. |
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