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xTAG® Gastrointestinal Pathogen Panel (GPP)

FDA UDI

Class II (US FDA UDI)

by Luminex Molecular Diagnostics, Inc.

Identity

Trade Name
xTAG® Gastrointestinal Pathogen Panel (GPP) FDA UDI
Generic Name
Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis. FDA UDI
Model / Reference
I032C0316 FDA UDI
Description
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis. FDA UDI

Identifiers

Catalog Number
I032C0316 FDA UDI
Primary DI / UDI-DI
00840487100493 FDA UDI
FDA Product Code
PCH FDA UDI
NSU FDA UDI
JJH FDA UDI
GMDN Term
Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3990 FDA UDI
862.2570 FDA UDI
862.2310 FDA UDI
Commercial Distribution
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

Category: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

xTAG® Gastrointestinal Pathogen Panel (GPP) by Luminex Molecular Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).

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 66b16d92-51f7-4e00-802d-61faf5c5cd15 36 fields · synced May 30, 2026