FDA.reportPublic FDA data

xTAG® RVP (Respiratory Viral Panel)

Primary DI
00840487100462
Brand
xTAG® RVP (Respiratory Viral Panel)
Company
Luminex Molecular Diagnostics, Inc
Model
I019C0111
Catalog number
I019C0111
Device description
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.
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
JJHCLINICAL SAMPLE CONCENTRATOR
NSUInstrumentation for clinical multiplex test systems
OCCRespiratory virus panel nucleic acid assay system
OEMHuman metapneumovirus (hmpv) rna assay system
OEPInfluenza a virus subtype differentiation nucleic acid assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OEMHuman Metapneumovirus (Hmpv) Rna Assay SystemMicrobiology2
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid AssayMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487100462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487100462008404871004628404871004620840487100462

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 Temperature-25 Degrees Celsius-15 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius6 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
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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Primary DI, Brand, Company table
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06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
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