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FDA 510(k)

Simplexa COVID-19 Direct

K-Number: K212147 · 2022-09-13

ApplicantDiasorin Molecular, LLC
Decision Date2022-09-13
Product CodeQQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa COVID-19 Direct is a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2022-09-13 under approval number K212147. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplexa COVID-19 Direct?

Simplexa COVID-19 Direct is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K212147.

When was Simplexa COVID-19 Direct approved by the FDA?

Simplexa COVID-19 Direct received FDA 510(k) clearance on 2022-09-13, under approval number K212147.

What company makes Simplexa COVID-19 Direct?

Simplexa COVID-19 Direct is manufactured by Diasorin Molecular, LLC.

What is the FDA product code for Simplexa COVID-19 Direct?

The FDA product code for Simplexa COVID-19 Direct is QQX.

Related Clinical Trials

NCT05092516 Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC) ACTIVE_NOT_RECRUITING

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: QQX)

K211079BioFire COVID-19 Test 2Biofire Defense, LLC K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. K221460BioFire COVID-19 Test 2Biofire Defense, LLC K230440Xpert® Xpress CoV-2 plusCepheid® K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc. K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular

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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