510(k) K242071

Device: Xpert Xpress CoV-2/Flu/RSV plus
Applicant: Cepheid
510(k) number: K242071
Product code: QOF
Decision: Substantially Equivalent (SESE)
Decision date: 2025-01-10
Date received: 2024-07-16
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: Dual Track
Statement or summary: Summary
Third party reviewed: N

Related Records

510(k)	Device	Applicant	Decision date
K252269	FINDER Flu A&B/SARS-CoV-2 Test	Baebies, Inc.	2026-03-30
K251742	VELO Respiratory Test	Lex Diagnostics Limited	2026-02-13
K251978	LIAISON NES FLU A/B, RSV & COVID-19	Diasorin Molecular, LLC	2025-12-23
K252387	Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)	Diasorin Molecular, LLC	2025-10-30
K250080	QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini	QIAGEN GmbH	2025-08-27
K243544	BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini	Biofire Diagnostics, LLC	2025-08-14
K243455	cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems	Roche Molecular Systems, Inc.	2025-07-31
K250996	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid®	2025-05-01
K250995	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid®	2025-05-01
K243406	cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test	Roche Molecular Systems, Inc.	2025-04-25
K243400	cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test	Roche Molecular Systems, Inc.	2025-04-25
K242526	Visby Medical Respiratory Health Test	Visby Medical, Inc.	2025-02-19
K241573	Alinity m Resp-4-Plex	Abbott Molecular, Inc.	2025-02-14
K241806	Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel	Life Technologies Corporation	2025-01-08
K241652	DASH® SARS-CoV-2 & Flu A/B Test	Nuclein, LLC	2024-12-20