FDA.reportPublic FDA data

Xpert EV

Primary DI
07332940000097
Brand
Xpert EV
Company
CEPHEID
Model
GXEV-100N-10
Catalog number
GXEV-100N-10
Device description
Xpert EV 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
OAIAssay, Enterovirus Nucleic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAIAssay, Enterovirus Nucleic AcidMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN070004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN070004000XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065Cepheid2007-03-16OAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940000097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940000097073329400000977332940000097

GMDN Terms#

Term, Definition table
TermDefinition
Multiple meningitis-associated microorganism 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 one or multiple microorgnamisms associated with meningitis, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2). ), varicella-zoster virus (VZV), and Mumps virus.

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