NTI

Product Code: NTI


Products Classified as NTI

6245Drug Metabolizing Enzyme Genotyping SystemsDrug Metabolizing Enzyme Genotyping System.

Total Product Life Cycle (TPLC) Devices

6245Drug Metabolizing Enzyme Genotyping SystemsDrug Metabolizing Enzyme Genotyping System.

FDA Consensus Standards

Drug Metabolizing Enzyme Genotyping Systems [30535]21 CFR §862.3360 🔎

Pre-market Notifications for NTI

K170492XTAG CYP2D6 Kit V3Luminex Molecular Diagnostics, Inc.
K131565XTAG CYP2C19 KIT V3LUMINEX MOLECULAR DIAGNOSTICS, INC.
K130189XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)LUMINEX MOLECULAR DIAGNOSTICS, INC.
K123891SPARTAN RX CYP2C19 TEST SYSTEMSPARTAN BIOSCIENCE INC
K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)NANOSPHERE, INC
K101683INFINITI CYP2C19 ASSAYAUTOGENOMICS, INCORPORATED
K093420XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)LUMINEX MOLECULAR DIAGNOSTICS, INC.
K051824INVADER UGT1A1 MOLECULAR ASSAYTHIRD WAVE TECHNOLOGIES, INC.
K043576ROCHE AMPLICHIP CYP450 TESTROCHE MOLECULAR SYSTEMS, INC.

Global Unique Device Identification Database

00850009370150Drug metabolizing enzyme genotyping systems
00850009370143Drug metabolizing enzyme genotyping systems
00840487101025Drug metabolizing enzyme genotyping systems
00840487100172Drug metabolizing enzyme genotyping systems
00840487100134Drug metabolizing enzyme genotyping systems
ASM00101Drug Metabolizing Enzyme Genotyping Systems

Maude Adverse Events

AMPLICHIP CYP450 TESTROCHE MOLECULAR SYSTEMS2011-11-03
AMPLICHIP CYP450 TESTROCHE MOLECULAR SYSTEMS2011-01-12
AMPLICHIP CYP450 TESTROCHE MOLECULAR SYSTEMS2010-05-19
AMPLICHIP CYP450 TEST, US-IVDROCHE MOLECULAR SYSTEMS2009-10-07
AMPLICHIP CYP450 TESTROCHE MOLECULAR SYSTEMS, INC.2007-03-09
AMPLICHIP CYP450 TESTROCHE MOLECULAR SYSTEMS2005-09-30
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