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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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 HBc IgM and LIAISON® XL MUREX Co... DiaSorin Inc. P180045 S013 11/08/2023
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Cont... DiaSorin Inc. P180048 S014 11/08/2023
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX C... DiaSorin Inc. P180049 S014 11/08/2023
LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Contr... DiaSorin Inc P190017 S017 11/08/2023
Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Ali... ABBOTT LABORATORIES INC P050051 S056 11/06/2023
Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests) Abbott Laboratories P060035 S041 11/06/2023
Alinity i Anti-HBc Reagent Kit (2x 100 Tests), Ali... Abbott Laboratories P080023 S043 11/06/2023
Alinity i HBsAg Qualitative II Reagent Kit (2x l 0... Abbott Laboratories P110029 S047 11/06/2023
Alinity i Anti-HBs Reagent Kit (2x100 Tests), Alin... ABBOTT LABORATORIES INC P050051 S055 11/03/2023
Alinity i Anti-HBc IgM Reagent Kit (2x100 Tests) Abbott Laboratories P060035 S040 11/03/2023
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