K-number	K812808
Device name	BBL DIRECTIGEN TEST KIT
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GTY
Device class	Class I
Decision date	Dec 30, 1981
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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BBL DIRECTIGEN TEST KIT

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