FDA Registered Clinical Toxicology Medical Devices List: DRUG METABOLIZING ENZYME GENOTYPING SYSTEMS

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Medical Specialty: Clinical Toxicology
Classification: DRUG METABOLIZING ENZYME GENOTYPING SYSTEMS

	Common Generic Device Name	Proprietary Device Name	Company
1	IN VITRO DIAGNOSTIC MOLECULAR TEST	INVADER UGT1A1 MOLECUALR ASSAY	THIRD WAVE TECHNOLOGIES, INC. 502 SOUTH ROSA RD. MADISON, WI 53719 US 608-204-2966 / 608-204-2966
2	CYTOCHROME P450 CYP2C19 TEST, CYTOCHROME P450 CYP2D6 TEST	ROCHE AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE PLEASANTON, CA 94588 US 925-730-8110 / 925-730-8110
3	CYTOCHROME P450 CYP2C19 TEST, CYTOCHROME P450 CYP2D6 TEST	ROCHE AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HWY. 202 1080 U.S. HWY. 202 SOMERVILLE, NJ 08876 US 925-730-8110 / 925-730-8110
4	CYTOCHROME P450 CYP2C19 TEST, CYTOCHROME P450 CYP2D6 TEST	ROCHE AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS, INC. 11 FRANKLIN AVE. BELLEVILLE, NJ 07109 US 925-730-8110 / 925-730-8110