FDA.reportPublic FDA data

NxTAG® Respiratory Pathogen Panel

Primary DI
00840487100417
Brand
NxTAG® Respiratory Pathogen Panel
Company
Luminex Molecular Diagnostics, Inc
Model
I051C0447
Catalog number
I051C0447
Device description
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.
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
OCCRespiratory virus panel nucleic acid assay system
OEMHuman metapneumovirus (hmpv) rna assay system
OEPInfluenza a virus subtype differentiation nucleic acid assay
OOIreal time Nucleic acid amplification system
OOUParainfluenza multiplex nucleic acid assay
OTGNon-sars coronavirus multiplex nucleic acid assay
OZXMycoplasma pneumoniae DNA assay system
OZYChlamydophila pneumoniae dna assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OEMHuman Metapneumovirus (Hmpv) Rna Assay SystemMicrobiology2
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid AssayMicrobiology2
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
OOUParainfluenza Multiplex Nucleic Acid AssayMicrobiology2
OTGNon-Sars Coronavirus Multiplex Nucleic Acid AssayMicrobiology2
OZXMycoplasma Pneumoniae Dna Assay SystemMicrobiology2
OZYChlamydophila Pneumoniae Dna Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152386000
K193167000
K242613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152386000NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareLuminex Molecular Diagnostics, Inc.2015-12-17OCC
K193167000NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareLuminex Molecular Diagnostics, Inc.2019-12-11OCC
K242613000NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.2024-10-02OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487100417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487100417008404871004178404871004170840487100417

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple viruses associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
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
00840487100172xTAG® CYP2C19 Kit v3I046B0427I046B04272016-09-09
00840487100479xTAG® Cystic Fibrosis (CFTR) 60 kit v2I024C0181I024C01812016-09-09

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