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510(k) K231481

Device
Xpert Xpress CoV-2/Flu/RSV plus
Applicant
Cepheid®
510(k) number
K231481
Product code
QOF
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-17
Date received
2023-05-23
Regulation
866.3981
Classification name
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Suzette Chance
Address
904 Caribbean Dr. Sunnyvale CA US 94089 94089

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QOF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.2026-03-30
K251742VELO Respiratory TestLex Diagnostics Limited2026-02-13
K251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLC2025-12-23
K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLC2025-10-30
K250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH2025-08-27
K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC2025-08-14
K243455cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc.2025-07-31
K250996Xpert Xpress CoV-2/Flu/RSV plusCepheid®2025-05-01
K250995Xpert Xpress CoV-2/Flu/RSV plusCepheid®2025-05-01
K243406cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.2025-04-25
K243400cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.2025-04-25
K242526Visby Medical Respiratory Health TestVisby Medical, Inc.2025-02-19
K241573Alinity m Resp-4-PlexAbbott Molecular, Inc.2025-02-14
K242071Xpert Xpress CoV-2/Flu/RSV plusCepheid2025-01-10
K241806Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelLife Technologies Corporation2025-01-08