xTAG® Cystic Fibrosis (CFTR) 39 kit v2 I027C0231

GUDID 00840487100141

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.

Luminex Molecular Diagnostics, Inc

Cystic fibrosis IVD, kit, multiplex
Primary Device ID00840487100141
NIH Device Record Key9943eb4c-1c23-4501-9e07-b92f24a61988
Commercial Distribution StatusIn Commercial Distribution
Brand NamexTAG® Cystic Fibrosis (CFTR) 39 kit v2
Version Model NumberI027C0231
Catalog NumberI027C0231
Company DUNS255371916
Company NameLuminex Molecular Diagnostics, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)785-2323
Emailsupport@luminexcorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840487100141 [Primary]

FDA Product Code

NUASystem, cystic fibrosis transmembrane conductance regulator, gene mutation detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-28
Device Publish Date2016-09-09

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Trademark Results [xTAG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XTAG
XTAG
88416429 not registered Live/Pending
Guangzhou Huaju Information Technology Co., Ltd.
2019-05-06
XTAG
XTAG
88023855 not registered Live/Pending
Seeonic, Inc.
2018-07-02
XTAG
XTAG
86770178 5033131 Live/Registered
Mobex, Inc.
2015-09-28
XTAG
XTAG
85187358 4025320 Dead/Cancelled
Alternatives Technologie Pharma Inc.
2010-11-30
XTAG
XTAG
79095998 4017961 Dead/Cancelled
XAVIER MUÑOZ BELLVEHÍ
2010-11-12

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