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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant SIEMENS HEALTHCARE DIAGNOSTICS productcode LOM Decision Date To 05/04/2024
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Atellica IM Anti-Hepatitis B Surface Antigen 2 (aH... SIEMENS HEALTHCARE DIAGNOSTICS P100039 S006 09/11/2018
Atellica IM Hepatitis B core IgM (aHBcM) assay; At... SIEMENS HEALTHCARE DIAGNOSTICS P030040 S014 08/24/2018
Atellica IM Hepatitis B e Antigen (HBeAg) SIEMENS HEALTHCARE DIAGNOSTICS P090024 S004 07/12/2018
Atellica IM Anti-Hepatitis B core Total (HBcT), At... SIEMENS HEALTHCARE DIAGNOSTICS P040004 S013 07/06/2018
Atellica IM Anti-Hepatitis B surface Antigen 2 (aH... SIEMENS HEALTHCARE DIAGNOSTICS P100039 S005 05/23/2018
Atellica IM Hepatitis B core Antigen (aHBcM) SIEMENS HEALTHCARE DIAGNOSTICS P030040 S012 05/03/2018
ADVIA Centaur HBeAg SIEMENS HEALTHCARE DIAGNOSTICS P090024 S003 04/25/2017
ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CE... SIEMENS HEALTHCARE DIAGNOSTICS P030040 S011 12/25/2016
ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P090024 S001 10/18/2016
ADVIA CENTAUR ANTI HBS2 ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P100039 S004 08/20/2016
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