FDA.reportPublic FDA data

xTAG® Gastrointestinal Pathogen Panel (GPP)

Primary DI
00840487100493
Brand
xTAG® Gastrointestinal Pathogen Panel (GPP)
Company
Luminex Molecular Diagnostics, Inc
Model
I032C0316
Catalog number
I032C0316
Device 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.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJHCLINICAL SAMPLE CONCENTRATOR
NSUInstrumentation for clinical multiplex test systems
PCHGastrointestinal pathogen panel multiplex nucleic acid-based assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487100493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487100493008404871004938404871004930840487100493

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal pathogen 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 types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)785-2323support@luminexcorp.com

Regulatory Flags#

DUNS number
255371916
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840487100417NxTAG® Respiratory Pathogen PanelI051C0447I051C04472016-09-09
00840487101872NxTAG® Respiratory Pathogen Panel v2I055C0465I055C04652024-06-20
00840487100134xTAG® CYP2D6 Kit v3I030B0373I030B03732016-09-09
00840487101025xTAG® CYP2D6 Kit v3I030E0443I030E04432016-09-09
00840487100462xTAG® RVP (Respiratory Viral Panel)I019C0111I019C01112016-09-09
00840487100486xTAG® RVP FAST (Respiratory Viral Panel Fast)I025C0197I025C01972016-09-09
00840487100455xTAG® Cystic Fibrosis Mutation Detection KitI006C0068I006C00682016-09-09
00840487100141xTAG® Cystic Fibrosis (CFTR) 39 kit v2I027C0231I027C02312016-09-09
00840487100172xTAG® CYP2C19 Kit v3I046B0427I046B04272016-09-09
00840487100479xTAG® Cystic Fibrosis (CFTR) 60 kit v2I024C0181I024C01812016-09-09

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