FDA.reportPublic FDA data

xTAG® Cystic Fibrosis Mutation Detection Kit

Primary DI
00840487100455
Brand
xTAG® Cystic Fibrosis Mutation Detection Kit
Company
Luminex Molecular Diagnostics, Inc
Model
I006C0068
Catalog number
I006C0068
Device description
The xTAG® Cystic Fibrosis Kit 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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUASystem, cystic fibrosis transmembrane conductance regulator, gene mutation detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation DetectionImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060627000TAG-IT CYSTIC FIBROSIS KITTm Bioscience Corporation2006-06-07NUA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487100455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487100455008404871004558404871004550840487100455

GMDN Terms#

Term, Definition table
TermDefinition
Cystic fibrosis IVD, kit, multiplexA 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
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 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
00840487100141xTAG® Cystic Fibrosis (CFTR) 39 kit v2I027C0231I027C02312016-09-09
00840487100172xTAG® CYP2C19 Kit v3I046B0427I046B04272016-09-09
00840487100479xTAG® Cystic Fibrosis (CFTR) 60 kit v2I024C0181I024C01812016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840487100479xTAG® Cystic Fibrosis (CFTR) 60 kit v2Luminex Molecular Diagnostics, IncNUA2016-09-09
00840487100141xTAG® Cystic Fibrosis (CFTR) 39 kit v2Luminex Molecular Diagnostics, IncNUA2016-09-09