K-number	K232092
Device name	Great Basin Toxigenic C. difficile Direct Test (CDF2)
Applicant	Vela Operations USA
Product code	OZN
Device class	Class II
Decision date	Nov 14, 2023
Decision	Substantially Equivalent
Regulation	866.3130

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View the full FDA submission: accessdata.fda.gov

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Great Basin Toxigenic C. difficile Direct Test (CDF2)

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