FDA 510(k) Applications Submitted by Cepheid«

FDA 510(k) Number Submission Date Device Name Applicant
K230440 02/21/2023 Xpert« Xpress CoV-2 plus Cepheid«
K250995 04/01/2025 Xpert Xpress CoV-2/Flu/RSV plus Cepheid«
K250996 04/01/2025 Xpert Xpress CoV-2/Flu/RSV plus Cepheid«
K231481 05/23/2023 Xpert Xpress CoV-2/Flu/RSV plus Cepheid«
K242109 07/19/2024 Xpert« Xpress CoV-2 plus (XPRS-COV2-10) Cepheid«
K243070 09/27/2024 Xpert« SA Nasal Complete Cepheid«
K223046 09/29/2022 Xpert« FII & FV Cepheid«
K243405 11/01/2024 Xpert vanA Cepheid«
K243625 11/25/2024 Xpert MRSA/SA SSTI Cepheid«
K243730 12/03/2024 Xpert C. difficile/Epi Cepheid«


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