Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LIAISON NES FLU A/B, RSV & COVID-19

K-Number: K251978 · 2025-12-23

ApplicantDiasorin Molecular, LLC
Decision Date2025-12-23
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON NES FLU A/B, RSV & COVID-19 is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251978. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON NES FLU A/B, RSV & COVID-19?

LIAISON NES FLU A/B, RSV & COVID-19 is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K251978.

When did LIAISON NES FLU A/B, RSV & COVID-19 receive FDA 510(k) clearance?

LIAISON NES FLU A/B, RSV & COVID-19 received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251978.

Who is the listed applicant for LIAISON NES FLU A/B, RSV & COVID-19?

The FDA 510(k) record lists Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON NES FLU A/B, RSV & COVID-19?

The FDA product code for LIAISON NES FLU A/B, RSV & COVID-19 is QOF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05765396SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)COMPLETED

Other records listing Diasorin Molecular, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)K220963Simplexa COVID-19 & Flu A/B DirectK202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackK212147Simplexa COVID-19 DirectK201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

View all 13 devices →

Related Devices (Code: QOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbHK243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑