Home GUDID 00840487100134 xTAG® CYP2D6 Kit v3
Primary DI 00840487100134
Brand xTAG® CYP2D6 Kit v3
Company Luminex Molecular Diagnostics, Inc
Model I030B0373
Catalog number I030B0373
Device description The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.
Published 2016-09-09
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name NTI Drug metabolizing enzyme genotyping systems
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NTI Drug Metabolizing Enzyme Genotyping Systems Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840487100134 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 00840487100134 00840487100134 840487100134 0840487100134
GMDN Terms# Term, Definition table Term Definition Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose or predict gene polymorphisms within the Cytochrome P450 superfamily (CYP450) that are associated with metabolism of xenobiotics/drugs, including warfarin, analgesics and/or anti-depressants, using a multiplex method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -25 Degrees Celsius -15 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 6 Degrees Celsius
Regulatory Flags# DUNS number 255371916 Device count 1 Kit 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 00840487100417 NxTAG® Respiratory Pathogen Panel I051C0447 I051C0447 2016-09-09 00840487101872 NxTAG® Respiratory Pathogen Panel v2 I055C0465 I055C0465 2024-06-20 00840487101025 xTAG® CYP2D6 Kit v3 I030E0443 I030E0443 2016-09-09 00840487100462 xTAG® RVP (Respiratory Viral Panel) I019C0111 I019C0111 2016-09-09 00840487100486 xTAG® RVP FAST (Respiratory Viral Panel Fast) I025C0197 I025C0197 2016-09-09 00840487100493 xTAG® Gastrointestinal Pathogen Panel (GPP) I032C0316 I032C0316 2016-09-09 00840487100455 xTAG® Cystic Fibrosis Mutation Detection Kit I006C0068 I006C0068 2016-09-09 00840487100141 xTAG® Cystic Fibrosis (CFTR) 39 kit v2 I027C0231 I027C0231 2016-09-09 00840487100172 xTAG® CYP2C19 Kit v3 I046B0427 I046B0427 2016-09-09 00840487100479 xTAG® Cystic Fibrosis (CFTR) 60 kit v2 I024C0181 I024C0181 2016-09-09
Other Devices Sharing Product Codes# 
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