K-number	K212147
Device name	Simplexa COVID-19 Direct
Applicant	Diasorin Molecular, LLC
Product code	QQX
Device class	Class II
Decision date	Sep 13, 2022
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 Direct

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