K-number	K220963
Device name	Simplexa COVID-19 & Flu A/B Direct
Applicant	Diasorin Molecular, LLC
Product code	QOF
Device class	Class II
Decision date	Mar 17, 2023
Decision	Substantially Equivalent
Regulation	866.3981

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Source

View the full FDA submission: accessdata.fda.gov

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Simplexa COVID-19 & Flu A/B Direct

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