xTAG® RVP (Respiratory Viral Panel)

FDA UDI

Class I (US FDA UDI)

by Luminex Molecular Diagnostics, Inc.

Identity

Trade Name: xTAG® RVP (Respiratory Viral Panel) FDA UDI
Generic Name: Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name: 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. FDA UDI
Model / Reference: I019C0111 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: I019C0111 FDA UDI
Primary DI / UDI-DI: 00840487100462 FDA UDI
FDA Product Code: JJH FDA UDI
OEP FDA UDI
OCC FDA UDI
NSU FDA UDI
OEM FDA UDI
GMDN Term: Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2310 FDA UDI
866.3980 FDA UDI
862.2570 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

xTAG® RVP (Respiratory Viral Panel) by Luminex Molecular Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Luminex Molecular Diagnostics, Inc.

Sources (1)

FDA UDI 15abee9c-cf18-40fb-ad28-31aee48b9f75 37 fields · synced Jun 8, 2026