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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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21 to 30 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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Alinity i Anti-HBc Reagent Kit (2x100 Tests), Alin... Abbott Laboratories P080023 S042 11/03/2023
Alinity i HBsAg Qualitative II Reagent Kit (2x100 ... Abbott Laboratories P110029 S046 11/03/2023
Elecsys Anti-HBs ROCHE DIAGNOSTICS CORP. P010054 S044 10/31/2023
Elecsys Anti-HBc II ROCHE DIAGNOSTICS CORP. P100031 S029 10/31/2023
Elecsys Anti-HBc IgM ROCHE DIAGNOSTICS CORP. P110022 S029 10/31/2023
Elecsys HBeAg ROCHE DIAGNOSTICS OPERATIONS I P130015 S018 10/31/2023
Elecsys HBsAg II, Elecsys HBsAg II Auto Confirm ROCHE DIAGNOSTICS, INC. P160019 S015 10/31/2023
Elecsys Anti-HBe Roche Diagnostics P190005 S003 10/31/2023
Elecsys Anti-HBs II Roche Diagnostics P190034 S004 10/31/2023
ARCHITECT AUSAB / Alinity i Anti-HBs ABBOTT LABORATORIES INC P050051 S051 10/11/2023
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