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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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41 to 50 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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LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX... DiaSorin Inc P190017 S015 09/28/2023
Alinity i HBsAg Next Qualitative assay, Alinity i ... Abbott Laboratories P210003 S006 09/28/2023
LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Co... DiaSorin Inc P190017 S014 08/22/2023
ARCHITECT AUSAB / Alinity i Anti-HBs ABBOTT LABORATORIES INC P050051 S054 07/10/2023
ARCHITECT CORE-M / Alinity i Anti-HBc IgM Abbott Laboratories P060035 S039 07/10/2023
ARCHITECT CORE / Alinity i Anti-HBc Abbott Laboratories P080023 S041 07/10/2023
ARCHITECT HBsAg Qualitative/ Qualitative Confirmat... Abbott Laboratories P110029 S045 07/10/2023
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg... Abbott Laboratories P210003 S008 07/10/2023
ARCHITECT HBsAg Qualitative/HBsAg Qualitative Conf... Abbott Laboratories P110029 S043 06/23/2023
ARCHITECT HBsAg Qualitative, HBsAg Qualitative Con... Abbott Laboratories P110029 S044 06/22/2023
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