Name: Predicase
Price: 199 USD

K-number	DEN230092
Device name	Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
Applicant	Diasorin Molecular, LLC
Product code	SBT
Device class	Class II
Decision date	Jul 15, 2024
Decision	Not Substantially Equivalent
Regulation	866.3967

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Source

View the full FDA submission: accessdata.fda.gov

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Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

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