Luminex Molecular Diagnostics, Inc

Luminex Molecular Diagnostics, Inc

Address:439 UNIVERSITY AVE.,TORONTO Ontario,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Influenza a virus subtype differentiation nucleic acid assay (OEP) (3) System, cystic fibrosis transmembrane conductance regulator, gene mutation detection (NUA) (3) Drug metabolizing enzyme genotyping systems (NTI) (3) Respiratory virus panel nucleic acid assay system (OCC) (3) Human metapneumovirus (hmpv) rna assay system (OEM) (3) CLINICAL SAMPLE CONCENTRATOR (JJH) (2) Instrumentation for clinical multiplex test systems (NSU) (2) Mycoplasma pneumoniae DNA assay system (OZX) (1) Non-sars coronavirus multiplex nucleic acid assay (OTG) (1) Parainfluenza multiplex nucleic acid assay (OOU) (1) Gastrointestinal pathogen panel multiplex nucleic acid-based assay system (PCH) (1) Chlamydophila pneumoniae dna assay system (OZY) (1) real time Nucleic acid amplification system (OOI) (1)

Premarket Exempt

No

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xTAG® CYP2D6 Kit v3 - 00840487100134 Catalog Number : I030B0373

Device Description : The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a 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.

Device Class : 2

Duns Number: 255371916

Premarket Exempt : No

Product Code : NTI

Prescription Use : Yes

Device Count : 1

xTAG® Cystic Fibrosis (CFTR) 39 kit v2 - 00840487100141 Catalog Number : I027C0231

Device Description : The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect an 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.

Device Class : 2

Duns Number: 255371916

Premarket Exempt : No

Product Code : NUA

Prescription Use : Yes

Device Count : 1

xTAG® CYP2C19 Kit v3 - 00840487100172 Catalog Number : I046B0427

Device Description : The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously d 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.

Device Class : 2

Duns Number: 255371916

Premarket Exempt : No

Product Code : NTI

Prescription Use : Yes

Device Count : 1

NxTAG® Respiratory Pathogen Panel - 00840487100417 Catalog Number : I051C0447

Device Description : The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection.

Device Class : 2

Duns Number: 255371916

Premarket Exempt : No

Product Code : OTG, OOI, OEP, OCC, OZX, OZY, OOU, OEM

Prescription Use : Yes

Device Count : 1

xTAG® Cystic Fibrosis Mutation Detection Kit - 00840487100455 Catalog Number : I006C0068

Device Description : The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and iden 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

Device Class : 2

Duns Number: 255371916

Premarket Exempt : No

Product Code : NUA

Prescription Use : Yes

Device Count : 1

xTAG® RVP (Respiratory Viral Panel) - 00840487100462 Catalog Number : I019C0111

Device Description : The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections.

Device Class : 1

Duns Number: 255371916

Premarket Exempt : No

Product Code : JJH, OEP, OCC, NSU, OEM

Prescription Use : Yes

Device Count : 1

xTAG® Cystic Fibrosis (CFTR) 60 kit v2 - 00840487100479 Catalog Number : I024C0181

Device Description : The xTAG® Cystic Fibrosis 60 Kit v2 is a device used to simultaneously detect an The xTAG® Cystic Fibrosis 60 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.

Device Class : 2

Duns Number: 255371916

Premarket Exempt : No

Product Code : NUA

Prescription Use : Yes

Device Count : 1

xTAG® RVP FAST (Respiratory Viral Panel Fast) - 00840487100486 Catalog Number : I025C0197

Device Description : The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected ofrespiratory tract infections

Device Class : 2

Duns Number: 255371916

Premarket Exempt : No

Product Code : OEM, OEP, OCC

Prescription Use : Yes

Device Count : 1

xTAG® Gastrointestinal Pathogen Panel (GPP) - 00840487100493 Catalog Number : I032C0316

Device Description : The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis.

Device Class : 1

Duns Number: 255371916

Premarket Exempt : No

Product Code : PCH, NSU, JJH

Prescription Use : Yes

Device Count : 1

xTAG® CYP2D6 Kit v3 - 00840487101025 Catalog Number : I030E0443

Device Description : The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a 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.

Device Class : 2

Duns Number: 255371916

Premarket Exempt : No

Product Code : NTI

Prescription Use : Yes

Device Count : 1

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