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 (100/200 tests) |
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 | S008 |
Date Received | 10/09/2018 |
Decision Date | 11/06/2018 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a secondary manufacturer/supplier of a component raw material. |
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