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 | Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD DEPT 9VA- AP8-1 ABBOTT PARK, IL 60064 |
PMA Number | P050051 |
Supplement Number | S056 |
Date Received | 08/11/2023 |
Decision Date | 11/06/2023 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the release of Alinity i Anti-HBs, Alinity i Anti-HBc IgM, Alinity I Anti-HBc, Alinity i HBsAg Qualitative II, and Alinity i Qualitative II Confirmatory for use with Alinity i (Alinity ci-series single and multimodule configuration) when connected to the GLP systems Track. |
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