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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 6 of 6 Results
510(K) Number: K140407
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FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Ga... 2 02/15/2024 BioFire Diagnostics, LLC
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vit... 2 01/10/2024 BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) 2 04/14/2023 BioFire Diagnostics, LLC
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 2 03/15/2023 BioFire Diagnostics, LLC
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE I... 2 03/06/2020 BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104,... 2 04/27/2019 BioFire Diagnostics, LLC
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