FDA.reportPublic FDA data

xTAG® CYP2C19 Kit v3

Primary DI
00840487100172
Brand
xTAG® CYP2C19 Kit v3
Company
Luminex Molecular Diagnostics, Inc
Model
I046B0427
Catalog number
I046B0427
Device description
The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTIDrug metabolizing enzyme genotyping systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTIDrug Metabolizing Enzyme Genotyping SystemsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131565000XTAG CYP2C19 KIT V3Luminex Molecular Diagnostics, Inc.2013-09-11NTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487100172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487100172008404871001728404871001720840487100172

GMDN Terms#

Term, Definition table
TermDefinition
Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplexA 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
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)785-2323support@luminexcorp.com

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 DIBrandModelCatalogPublished
00840487100417NxTAG® Respiratory Pathogen PanelI051C0447I051C04472016-09-09
00840487101872NxTAG® Respiratory Pathogen Panel v2I055C0465I055C04652024-06-20
00840487100134xTAG® CYP2D6 Kit v3I030B0373I030B03732016-09-09
00840487101025xTAG® CYP2D6 Kit v3I030E0443I030E04432016-09-09
00840487100462xTAG® RVP (Respiratory Viral Panel)I019C0111I019C01112016-09-09
00840487100486xTAG® RVP FAST (Respiratory Viral Panel Fast)I025C0197I025C01972016-09-09
00840487100493xTAG® Gastrointestinal Pathogen Panel (GPP)I032C0316I032C03162016-09-09
00840487100455xTAG® Cystic Fibrosis Mutation Detection KitI006C0068I006C00682016-09-09
00840487100141xTAG® Cystic Fibrosis (CFTR) 39 kit v2I027C0231I027C02312016-09-09
00840487100479xTAG® Cystic Fibrosis (CFTR) 60 kit v2I024C0181I024C01812016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G257ASM000960Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
G257ASM000990Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
G257ASM001010Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
G257ASM001030Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
G257ASM001160Genomadix Cube CYP2C19Genomadix IncNTI2024-06-14
ASM00101Genomadix Cube CYP2C19,Genomadix IncNTI2023-07-18
00850009370136INFINITI® CYP2C19 BioFilmChip® Microarray MagazineAUTOGENOMICS, INCNTI2019-10-23
00850009370143INFINITI® CYP2C19 Intellipac® Reagent ModuleAUTOGENOMICS, INCNTI2019-10-23
00850009370150INFINITI® CYP2C19 Amplification MixAUTOGENOMICS, INCNTI2019-10-23
00628055420019Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420026Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420033Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420040Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420057Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420064Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420071Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420088Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420095Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00628055420101Spartan RX CYP2C19 SystemSpartan Bioscience IncNTI2016-09-26
00840487100134xTAG® CYP2D6 Kit v3Luminex Molecular Diagnostics, IncNTI2016-09-09
00840487101025xTAG® CYP2D6 Kit v3Luminex Molecular Diagnostics, IncNTI2016-09-09