Name: Predicase
Price: 199 USD

K-number	K141133
Device name	VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
Applicant	BIOMERIEUX
Product code	LYR
Device class	Class I
Decision date	Jul 9, 2015
Decision	Substantially Equivalent
Regulation	866.3110

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View the full FDA submission: accessdata.fda.gov

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VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II

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