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FDA 510(k)

Simplexa COVID-19 & Flu A/B Direct

K-Number: K220963 · 2023-03-17

ApplicantDiasorin Molecular, LLC
Decision Date2023-03-17
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa COVID-19 & Flu A/B Direct 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 2023-03-17 under 510(k) number K220963. 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 Simplexa COVID-19 & Flu A/B Direct?

Simplexa COVID-19 & Flu A/B Direct is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K220963.

When did Simplexa COVID-19 & Flu A/B Direct receive FDA 510(k) clearance?

Simplexa COVID-19 & Flu A/B Direct received FDA 510(k) clearance on 2023-03-17, under 510(k) number K220963.

Who is the listed applicant for Simplexa COVID-19 & Flu A/B Direct?

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 Simplexa COVID-19 & Flu A/B Direct?

The FDA product code for Simplexa COVID-19 & Flu A/B Direct is QOF.

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 KitK251978LIAISON NES FLU A/B, RSV & COVID-19K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)K202755Simplexa 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 LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ 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 GmbH

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.

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