FDA.reportPublic FDA data

Xpert Norovirus

Primary DI
07332940000974
Brand
Xpert Norovirus
Company
CEPHEID
Model
GXNOV-10
Catalog number
GXNOV-10
Device description
Xpert Norovirus kit; 10 test kit
Published
2018-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142501000Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheid2014-11-26PCH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940000974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940000974073329400009747332940000974

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 Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 888 838 3222techsupport@cepheid.com

Regulatory Flags#

DUNS number
956711444
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
07332940009489XpertGXGI-10GXGI-102026-01-30
07332940009694GeneXpert®GX-IV R22026-01-19
07332940009700GeneXpert® XpressGX-IV Xpress2026-01-19
07332940007072Xpert®XPRSMVP-10XPRSMVP-102022-04-13
07332940000196Xpert MRSAGXMRSA-100N-10GXMRSA-100N-102018-01-29
07332940000240Xpert Factor II & Factor VGXFIIFV-10GXFIIFV-102018-01-29
07332940001711Xpert MRSA NxGGXMRSA-NXG-10GXMRSA-NXG-102018-01-29
07332940001728Xpert MRSA NxGGXMRSA-NXG-120GXMRSA-NXG-1202018-01-29
07332940002442Xpert MRSAGXMRSA-120GXMRSA-1202018-01-29
07332940009519GeneXpert® GXFIIFV-US-10GXFIIFV-US-102025-11-21
07332940009687GeneXpert®GeneXpert XVI (GX-XVI)2025-08-15
07332940008161GeneXpert®XPRSGBS-10XPRSGBS-102024-02-16
07332940009243GeneXpert® XpressGX-IV XpressGX-IV Xpress2023-10-20
07332940007195GeneXpert®GXIV-HUB900-08282022-05-12
07332940007683GeneXpert®GX-II R2GX-II R22022-05-03
07332940007690GeneXpert®GX-IV R2GX-IV R22022-05-03
07332940007706GeneXpert®GX-XVI R2GX-XVI R22022-05-03
07332940007713GeneXpert®GX-INFINITY 48SGX-INFINITY 48S2022-05-03
07332940007720GeneXpert®GX-INFINITY 80GX-INFINITY 802022-05-03
07332940001360GeneXpert Dx SystemGXI-1900-04902016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840487101438LIAISON PLEX Gastrointestinal Flex AssayLUMINEX CORPORATIONPCH2026-06-08
07332940009489XpertCEPHEIDPCH2026-01-30
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00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
15420045517486Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517493Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517509Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517516Panther Fusion®Hologic, Inc.PCH2025-10-07
04053228048381QIAstat-Dx® GI Panel 2 Mini BQIAGEN GmbHPCH2025-03-28
00815381020888BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidBIOFIRE DIAGNOSTICS, LLCPCH2025-02-18
00815381020963BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidBIOFIRE DIAGNOSTICS, LLCPCH2025-02-18
04053228049166QIAstat-Dx® GI Panel 2 Mini B&VQIAGEN GmbHPCH2025-02-18
09351179004070EasyScreen™ Gastrointestinal Parasite PCR Positive ControlGENETIC SIGNATURES LIMITEDPCH2024-06-18
04053228043249QIAstat-Dx® Gastrointestinal Panel 2QIAGEN GmbHPCH2024-06-17
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYPCH2024-06-07
00382904431594BD Pre-warm HeaterBECTON, DICKINSON AND COMPANYPCH2024-03-19
00382904439859BD MAX™ Enteric Viral PanelBECTON, DICKINSON AND COMPANYPCH2020-02-19
00840487101520Enteric Pathogens (EP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONPCH2019-12-05
00840487101544Enteric Pathogens (EP) Amplification TrayLUMINEX CORPORATIONPCH2019-12-05
00840487101551Enteric Pathogens (EP) Extraction TrayLUMINEX CORPORATIONPCH2019-12-05
00840487101568Enteric Pathogens (EP) Stool Sample Preparation KitLUMINEX CORPORATIONPCH2019-12-05
00382904438128BD MAX™ Extended Enteric Bacterial PanelBECTON, DICKINSON AND COMPANYPCH2019-01-03
00851034007004BioCode MDx 3000APPLIED BIOCODE, INC.PCH2018-10-15
00851034007011Gastrointestinal Pathogen Panel (GPP) KitAPPLIED BIOCODE, INC.PCH2018-10-15
B178GBSBPP100Stool Bacterial Pathogens PanelGREAT BASIN SCIENTIFIC, INC.PCH2017-07-24
00382904429607BD MAX™ Enteric Parasite PanelBECTON, DICKINSON AND COMPANYPCH2016-10-17
00382904429638BD MAX™ Enteric Bacterial PanelBECTON, DICKINSON AND COMPANYPCH2016-10-17
B178GBSTEC100Shiga Toxin Direct TestGREAT BASIN SCIENTIFIC, INC.PCH2016-09-23
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