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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 64 Results
productcode LOM PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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VITROS Anti-HBc IgM Ortho-Clinical Diagnostics, In P030026 S037 01/24/2023
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S018 01/24/2023
VITROS Immunodiagnostic Products Anti-HBe Reagent ... ORTHO-CLINICAL DIAGNOSTICS P100001 S017 01/24/2023
ARCHITECT AUSAB / Alinity i Anti-HBs ABBOTT LABORATORIES INC P050051 S049 01/30/2023
ADVIA Centaur® and Atellica IM Hepatitis B Core Ig... SIEMENS HEALTHCARE DIAGNOSTICS P030040 S022 02/06/2023
LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX HBsA... DiaSorin Inc P190017 S009 04/13/2023
Elecsys HBsAg II, PreciControl HBsAg II, Elecsys H... ROCHE DIAGNOSTICS, INC. P160019 S014 04/24/2023
ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica ... Siemens Healthcare Diagnostics P210019 S002 04/28/2023
Elecsys Anti-HBc II ROCHE DIAGNOSTICS CORP. P100031 S028 05/08/2023
ARCHITECT HBsAg Next Qualitative and ARCHITECT HBs... Abbott Laboratories P210003 S004 05/08/2023
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