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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 a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2023-03-17 under approval 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. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K220963.

When was Simplexa COVID-19 & Flu A/B Direct approved by the FDA?

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

What company makes Simplexa COVID-19 & Flu A/B Direct?

Simplexa COVID-19 & Flu A/B Direct is manufactured by Diasorin Molecular, LLC.

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.

Related Clinical Trials

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Other Devices by Diasorin Molecular, LLC

K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack K182467Simplexa GBS Direct, Simplexa GBS Positive Control Pack K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack K173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack K190219Simplexa VZV Direct, Simplexa VZV Positive Control Pack

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Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBd Integrated Diagnostic Solutions / K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K230719BIOFIRE® SPOTFIRE® Respiratory (R) 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.

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