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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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