Home GUDID 00840487100141 xTAG® Cystic Fibrosis (CFTR) 39 kit v2
Primary DI 00840487100141
Brand xTAG® Cystic Fibrosis (CFTR) 39 kit v2
Company Luminex Molecular Diagnostics, Inc
Model I027C0231
Catalog number I027C0231
Device description The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.
Published 2016-09-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name NUA System, cystic fibrosis transmembrane conductance regulator, gene mutation detection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840487100141 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 00840487100141 00840487100141 840487100141 0840487100141
GMDN Terms# Term, Definition table Term Definition Cystic fibrosis IVD, kit, multiplex A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene, 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 00840487100134 xTAG® CYP2D6 Kit v3 I030B0373 I030B0373 2016-09-09 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 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840487100455 xTAG® Cystic Fibrosis Mutation Detection Kit Luminex Molecular Diagnostics, Inc NUA 2016-09-09 00840487100479 xTAG® Cystic Fibrosis (CFTR) 60 kit v2 Luminex Molecular Diagnostics, Inc NUA 2016-09-09
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