Home GUDID 00850009370174 INFINITI® Warfarin Intellipac® Reagent Module
Primary DI 00850009370174
Brand INFINITI® Warfarin Intellipac® Reagent Module
Company AUTOGENOMICS, INC
Model 03-2140-01
Catalog number 03-2140-01
Device description CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
Published 2019-10-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name ODV Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system ODW Cytochrome P450 2C9 (Cyp450 2c9) drug metabolizing enzyme genotyping system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODV Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System Hematology 2 ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850009370174 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850009370174 00850009370174 850009370174 0850009370174
GMDN Terms# Term, Definition table Term Definition Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to predict or monitor the genetic predisposition of a patient exhibiting resistance to anticoagulation agents based on multiple genetic markers which may include the Cytochrome P450 superfamily (CYP450) and Vitamin K epoxide reductase complex subunit-1 (VKORC1) gene polymorphisms, using a nucleic acid technique (NAT). It is used to aid therapy management of patients with thromboembolic disease typically treated with coumarin derivatives (e.g., warfarin).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 027914535 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10850009370249 AvertD™ (96) PE Mix 03-6560-01 03-6560-01 2024-11-18 10850009370256 AvertD™ (96) AMP Mix 03-7560-01 03-7560-01 2024-11-18 10850009370232 AvertD™ (96) Tube 03-5560-01 03-5560-01 2024-11-18 30850009370243 AvertD™ (96) PE Mix 03-6560-01 03-6560-01 2024-11-18 30850009370250 AvertD™ (96) AMP Mix 03-7560-01 03-7560-01 2024-11-18 10850009370195 AvertD™ Amplification Mix 03-3560-01 03-3560-01 2024-05-31 10850009370201 AvertD™ Intellipac Reagent Module 03-2560-01 03-2560-01 2024-05-31 10850009370218 AvertD™ BioFilmChip Microarray Magazine 03-1560-01 03-1560-01 2024-05-31 10850009370225 AvertD™ Buccal Sample Collection Kit 12-0610-01 12-0610-01 2024-05-31 00850009370006 INFINITI® PLUS ANALYZER 10-0020-99 10-0020-99 2019-10-23 00850009370013 INFINITI® High Throughput System (HTS) ACE ANALYZER 10-0030-99 10-0030-99 2019-10-23 00850009370020 INFINITI® High Throughput System (HTS) PROCESSOR 10-0060-99 10-0060-99 2019-10-23 00850009370037 INFINITI® High Throughput System (HTS) INCUBATOR 10-0070-99 10-0070-99 2019-10-23 00850009370044 INFINITI® Factor II BioFilmChip® Microarray Magazine 01-1020-01 01-1020-01 2019-10-23 00850009370051 INFINITI® Factor II Intellipac® Reagent Module 01-2020-01 01-2020-01 2019-10-23 00850009370068 INFINITI® Factor II Amplification Mix 01-3020-01 01-3020-01 2019-10-23 00850009370075 INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine 01-1030-01 01-1030-01 2019-10-23 00850009370082 INFINITI® Factor V Leiden Intellipac® Reagent Module 01-2030-01 01-2030-01 2019-10-23 00850009370099 INFINITI® Factor V Leiden Amplification Mix 01-3030-01 01-3030-01 2019-10-23 00850009370105 INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine 01-1050-01 01-1050-01 2019-10-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B648C724352616201 Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE® CURITEVA, INC. ODV 2025-12-29 00850009370167 INFINITI® Warfarin BioFilmChip® Microarray Magazine AUTOGENOMICS, INC ODV 2019-10-23 00850009370167 INFINITI® Warfarin BioFilmChip® Microarray Magazine AUTOGENOMICS, INC ODW 2019-10-23 00850009370181 INFINITI® Warfarin Amplification Mix AUTOGENOMICS, INC ODW 2019-10-23 00850009370181 INFINITI® Warfarin Amplification Mix AUTOGENOMICS, INC ODV 2019-10-23
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