xTAG® RVP (Respiratory Viral Panel)

Basic Information

• Brand Name: xTAG® RVP (Respiratory Viral Panel)
• Primary DI: 00840487100462
• Version / Model: I019C0111
• Catalog Number: I019C0111
• 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: 7
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 15abee9c-cf18-40fb-ad28-31aee48b9f75
• Distribution End Date: 2019-12-20

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.

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
JJH	CLINICAL SAMPLE CONCENTRATOR	Clinical Chemistry	862.2310	1
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
NSU	Instrumentation for clinical multiplex test systems	Clinical Chemistry	862.2570	2
OEM	Human metapneumovirus (hmpv) rna 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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840487100462	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 6 Degrees Celsius