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U.S. Department of Health and Human Services

510(k) Premarket Notification
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61 to 70 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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xpert xpress mvp, genexpert dx system, genexpert infinity system Cepheid K212213 02/09/2022
xpert xpress mvp, genexpert dx system, genexpert infinity system Cepheid K221160 06/07/2022
xpert xpress flu/rsv, xpert nasopharyngeal sample collection kit, xpert nasal sample collection kit, genexpert xpress ii, genexpert xpress iv Cepheid K180218 07/24/2018
xpert xpress flu/rsv, xpert nasopharyngeal sample collection kit, genexpert dx systems (gx-i, gx-ii, gx-iv, gx-xvi), genexpert infinity-48 system and genexpert infinity-48s system, genexpert infinity-80 system CEPHEID K162331 02/09/2017
xpert xpress flu, xpert nasopharyngeal sample collection kit, xpert nasal sample collection kit, genexpert xpress ii, genexpert xpress iv Cepheid K171552 12/19/2017
xpert xpress flu, xpert nasopharyngeal sample collection kit, xpert nasal sample collection kit, genexpert dx systems (gx-i, gx-ii, gx-iv, gx-xvi), genexpert infinity-48s system and genexpert infinity-80 system Cepheid K181289 08/15/2018
xpert xpress flu, xpert nasopharyngeal sample collection kit, genexpert dx systems (gx-i, gx-ii, gx-iv, gx-xvi), genexpert infinity-48 system and genexpert infinity-48s system, genexpert infinity-80 system CEPHEID K162456 02/13/2017
xpert xpress cov-2/flu/rsv plus Cepheid® K231481 08/17/2023
xpert vana assay CEPHEID K092953 12/17/2009
xpert tv, xpert urine specimen collection kit, genexpert dx systems (gx-i, gx-ii, gx-iv, gx-xvi), genexpert infinity-48, genxpert infinity-48s and genexpert infinity-80 systems Cepheid K161619 08/29/2016

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