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xTAG® RVP FAST (Respiratory Viral Panel Fast)

FDA UDI

Class II (US FDA UDI)

by Luminex Molecular Diagnostics, Inc.

Identity

Trade Name
xTAG® RVP FAST (Respiratory Viral Panel Fast) 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 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 FDA UDI
Model / Reference
I025C0197 FDA UDI
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 FDA UDI

Identifiers

Catalog Number
I025C0197 FDA UDI
Primary DI / UDI-DI
00840487100486 FDA UDI
FDA Product Code
OEM FDA UDI
OEP FDA UDI
OCC FDA UDI
GMDN Term
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3980 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Luminex Molecular Diagnostics, Inc.

Sources (1)

  • FDA UDI 71ef1470-7cf2-4118-927f-92cd3267a95e 37 fields · synced May 30, 2026