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Device | Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC) |
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 | S014 |
Date Received | 08/15/2018 |
Decision Date | 08/24/2018 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for change of the proprietary names of Atellica IM Hepatitis B core Antigen (aHBcM) and Atellica IM Hepatitis B Core Antigen Quality Control (aHBcM QC) to Atellica IM Hepatitis B core lgM (aHBcM) assay and Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC). |