K-number	K831991
Device name	DIRECTIGEN GROUP B STREP TEST KIT-SERUM
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GTZ
Device class	Class I
Decision date	Sep 26, 1983
Decision	Substantially Equivalent
Regulation	866.3740

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DIRECTIGEN GROUP B STREP TEST KIT-SERUM

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