FDA.reportPublic FDA data

Xpert C. difficile/Epi

Primary DI
07332940000042
Brand
Xpert C. difficile/Epi
Company
CEPHEID
Model
GXCDIFF/EPI-120
Catalog number
GXCDIFF/EPI-120
Device description
Xpert C. difficile/Epi kit; 120 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
OMNC. Difficile Nucleic Acid Amplification Test Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMNC. Difficile Nucleic Acid Amplification Test AssayMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110203000XPERT C. DIFFICLE/EPI ASSAYCepheid2011-04-07OMN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940000042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940000042073329400000427332940000042

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile 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, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius28 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
07332940000974Xpert NorovirusGXNOV-10GXNOV-102018-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733102134Alethia™ C. difficile External Control KitMERIDIAN BIOSCIENCE, INC.OMN2019-01-09
00840733102172Alethia™ C. difficileMERIDIAN BIOSCIENCE, INC.OMN2019-01-09
07332940000028Xpert C. difficile/EpiCEPHEIDOMN2018-01-29
00840733101120illumigene C. difficile External Control KitMERIDIAN BIOSCIENCE, INC.OMN2016-09-23
00840733101168illumigene C. difficileMERIDIAN BIOSCIENCE, INC.OMN2016-09-23
B178GBCDIFF100Portrait Toxigenic C. difficile AssayGREAT BASIN SCIENTIFIC, INC.OMN2016-09-23
20816101025583Simplexa™ C. difficile Universal DirectDIASORIN MOLECULAR LLCOMN2016-09-22