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Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

FDA product code ODW · Class 2 · Clinical Toxicology

3
Registered devices
0
Adverse events
1
Recalls
6
510(k) clearances

Devices with this code

INFINITI® Warfarin Intellipac® Reagent Module — AUTOGENOMICS, INCINFINITI® Warfarin Amplification Mix — AUTOGENOMICS, INCINFINITI® Warfarin BioFilmChip® Microarray Magazine — AUTOGENOMICS, INC

Recent recalls

DateFirmReason
2008-02-25Nanosphere, Inc.Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).

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