FDA.reportPublic FDA data

GeneXpert Dx System

Primary DI
07332940003371
Brand
GeneXpert Dx System
Company
CEPHEID
Model
GXIV-2
Catalog number
900-0140
Device description
XPERT, GENEXPERT DX SYSTEM
Published
2018-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestMicrobiology1
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060540000
K173263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060540000XPERT, GENEXPERT DX SYSTEMCepheid2006-07-25NJR
K173263000Xpert Carba-RCepheid2018-01-09POC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940003371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940003371073329400033717332940003371

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18888383222techsupport@cepheid.com

Regulatory Flags#

DUNS number
956711444
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332940010089Xpert®XPRSCOV2/FLU-10XPRSCOV2/FLU-102026-10-29
07332940009267Xpert®GXRESP-10GXRESP-102026-10-08
07332940003388GeneXpert Dx SystemGXIV-4900-01382018-05-09
07332940003449GeneXpert Dx SystemGXIV-4900-00652018-05-09
07332940006709GeneXpert Dx SystemGXIV-3900-01392018-05-09
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

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