NTI

Product Code: NTI

Products Classified as NTI

Drug Metabolizing Enzyme Genotyping Systems

Drug Metabolizing Enzyme Genotyping System.

Total Product Life Cycle (TPLC) Devices

Drug Metabolizing Enzyme Genotyping Systems

Drug Metabolizing Enzyme Genotyping System.

FDA Consensus Standards

Drug Metabolizing Enzyme Genotyping Systems [30535]

21 CFR §862.3360 🔎

Pre-market Notifications for NTI

K170492	XTAG CYP2D6 Kit V3	Luminex Molecular Diagnostics, Inc.
K131565	XTAG CYP2C19 KIT V3	LUMINEX MOLECULAR DIAGNOSTICS, INC.
K130189	XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)	LUMINEX MOLECULAR DIAGNOSTICS, INC.
K123891	SPARTAN RX CYP2C19 TEST SYSTEM	SPARTAN BIOSCIENCE INC
K120466	VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)	NANOSPHERE, INC
K101683	INFINITI CYP2C19 ASSAY	AUTOGENOMICS, INCORPORATED
K093420	XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)	LUMINEX MOLECULAR DIAGNOSTICS, INC.
K051824	INVADER UGT1A1 MOLECULAR ASSAY	THIRD WAVE TECHNOLOGIES, INC.
K043576	ROCHE AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS, INC.

Global Unique Device Identification Database

00850009370150	Drug metabolizing enzyme genotyping systems
00850009370143	Drug metabolizing enzyme genotyping systems
00840487101025	Drug metabolizing enzyme genotyping systems
00840487100172	Drug metabolizing enzyme genotyping systems
00840487100134	Drug metabolizing enzyme genotyping systems
ASM00101	Drug Metabolizing Enzyme Genotyping Systems
G257ASM001160	Drug Metabolizing Enzyme Genotyping Systems
G257ASM001030	Drug Metabolizing Enzyme Genotyping Systems
G257ASM001010	Drug Metabolizing Enzyme Genotyping Systems
G257ASM000990	Drug Metabolizing Enzyme Genotyping Systems
G257ASM000960	Drug Metabolizing Enzyme Genotyping Systems

Maude Adverse Events

AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS	2011-11-03
AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS	2011-01-12
AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS	2010-05-19
AMPLICHIP CYP450 TEST, US-IVD	ROCHE MOLECULAR SYSTEMS	2009-10-07
AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS, INC.	2007-03-09
AMPLICHIP CYP450 TEST	ROCHE MOLECULAR SYSTEMS	2005-09-30

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