xTAG® RVP FAST (Respiratory Viral Panel Fast)

DI: 00840487100486 · Model: I025C0197 · Luminex Molecular Diagnostics, Inc

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

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Basic Information

Brand Name: xTAG® RVP FAST (Respiratory Viral Panel Fast)
Primary DI: 00840487100486
Version / Model: I025C0197
Catalog Number: I025C0197
Company Name: Luminex Molecular Diagnostics, Inc
Labeler DUNS: 255371916
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-09
Public Version: 6
Public Version Date: 2023-12-18
Public Version Status: Update
Public Device Record Key: 71ef1470-7cf2-4118-927f-92cd3267a95e
Distribution End Date: 2020-01-02

Device Description

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 of respiratory tract infections

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEM	Human metapneumovirus (hmpv) rna assay system	Microbiology	866.3980	2
OEP	Influenza a virus subtype differentiation nucleic acid assay	Microbiology	866.3980	2
OCC	Respiratory virus panel nucleic acid assay system	Microbiology	866.3980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47922	Multiple-genus 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 multiple virus genera 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. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active