K-number	K011709
Device name	UNI-GOLD STREP A TEST KIT
Applicant	Trinity Biotech, Plc
Product code	GTZ
Device class	Class I
Decision date	Nov 8, 2001
Decision	Substantially Equivalent
Regulation	866.3740

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Source

View the full FDA submission: accessdata.fda.gov

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UNI-GOLD STREP A TEST KIT

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