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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 the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2022-09-13 under 510(k) 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. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K212147.

When did Simplexa COVID-19 Direct receive FDA 510(k) clearance?

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

Who is the listed applicant for Simplexa COVID-19 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 Direct?

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

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)K220963Simplexa COVID-19 & Flu A/B DirectK202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackK201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

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Related Devices (Code: QQX)

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.

K243396Aptima SARS-CoV-2 AssayHologic, Inc.K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsRoche Molecular Systems, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott MolecularK233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitLife Technologies CorporationK230440Xpert® Xpress CoV-2 plusCepheid®

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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