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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 8 of 8 Results
ProductCode: NQX Applicant: CEPHEID Decision Date To: 03/29/2024
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xpert mrsa CEPHEID K070462 04/17/2007
xpert mrsa/sa blood culture assay CEPHEID K082140 09/29/2008
xpert mrsa/sa ssti assay CEPHEID K080837 09/24/2008
xpert mrsa/sa bc (blood culture) assay model gxmrsa/sa-bc-10 CEPHEID K101879 07/28/2010
xpert mrsa/sa nasal assay CEPHEID K100822 06/01/2010
xpert mrsa/sa blood culture assay; genexpert dx systems (gx-i, gx-ii, gx-iv, gx-xvi); genexpert infinity-48 system; gene CEPHEID K130894 06/20/2013
xpert mrsa nxg CEPHEID K162444 11/23/2016
xpert mrsa/sa blood culture, genexpert dx system, genexpert infinity-48s system, genexpert infinity-80 system Cepheid K190771 04/25/2019
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