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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: LSL Applicant: CEPHEID Decision Date To: 05/05/2024
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xpert ct/ng, genexpert dx system, genexpert infinity-48s and genexpert infinity-80 systems, genexpert infinity-48 system, xpert vaginal/endocervical specimen collection, xpert urine specimen collection kit, xpert swab specimen collection kit Cepheid K190441 05/23/2019
xpert ct/ng Cepheid K173840 03/16/2018
xpert ct/ng CEPHEID K121710 12/27/2012
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