ODW · Class II · 21 CFR 862.3360

FDA Product Code ODW: Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

An In Vitro Diagnostic Assay For Use In Genotyping Cytochrome P450 2c9 (cyp450 2c9) Alleles. Information About The Cyp2c9 Genotype May Be Used As An Aid To Clinicians In Determining Therapeutic Strategy For Medications That Are Metabolized By The Cyp2c9 Gene Product.

Leading manufacturers include Genmark Diagnostics, Incorporated, Akonni Biosystems, Inc. and Nanosphere, Inc..

6
Total
6
Cleared
224d
Avg days
2007
Since

FDA 510(k) Cleared Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System Devices (Product Code ODW)

6 devices
1–6 of 6
Cleared May 24, 2019
TruDiagnosis System
K183530
Akonni Biosystems, Inc.
Toxicology · 156d
Cleared May 26, 2016
eSensor Warfarin Sensitivity Saliva Test
K152612
Genmark Diagnostics, Incorporated
Chemistry · 255d
Cleared Feb 06, 2009
EQ-PRC LC WARFARIN GENOTYPING KIT
K073071
Trimgen Corporation
Toxicology · 464d
Cleared Jul 17, 2008
ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
K073720
Osmetech Molecular Diagnostics
Toxicology · 199d
Cleared Jan 23, 2008
INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
K073014
Autogenomics, Incorporated
Toxicology · 90d
Cleared Sep 17, 2007
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
K070804
Nanosphere, Inc.
Toxicology · 178d

About Product Code ODW - Regulatory Context