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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 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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ARCHITECT CORE-M / Alinity i Anti-HBc IgM Abbott Laboratories P060035 S038 10/11/2023
ARCHITECT CORE / Alinity i Anti-HBc Abbott Laboratories P080023 S040 10/11/2023
ARCHITECT HBsAg Qualitative / HBsAg Qualitative Co... Abbott Laboratories P110029 S042 10/11/2023
ARCHITECT HBsAg Next Qualitative / Next Confirmato... Abbott Laboratories P210003 S007 10/11/2023
LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex... DiaSorin Inc P190017 S016 10/05/2023
LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX C... DiaSorin Inc. P180038 S015 09/28/2023
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Cont... DiaSorin Inc. P180039 S014 09/28/2023
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Contr... DiaSorin Inc. P180045 S012 09/28/2023
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Cont... DiaSorin Inc. P180048 S012 09/28/2023
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX C... DiaSorin Inc. P180049 S013 09/28/2023
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