FDA.reportPublic FDA data

Xpert®

Primary DI
07332940007072
Brand
Xpert®
Company
CEPHEID
Model
XPRSMVP-10
Catalog number
XPRSMVP-10
Device description
Xpert Xpress MVP
Published
2022-04-13
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
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212213000
K221160000
K231381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212213000Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid2022-02-09PQA
K221160000Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid2022-06-07PQA
K231381000Xpert Xpress MVP; GeneXpert Xpress SystemCepheid2023-10-19PQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940007072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940007072073329400070727332940007072

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type vaginitis-associated organism 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 organisms associated with vaginitis in a clinical specimen, using a nucleic acid technique (NAT). Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
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
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
07332940001360GeneXpert Dx SystemGXI-1900-04902016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045517059Aptima®Hologic, Inc.PQA2024-12-19
15420045517066Aptima®Hologic, Inc.PQA2024-12-19
15420045517073Aptima®Hologic, Inc.PQA2024-12-19
15420045517080Aptima®Hologic, Inc.PQA2024-12-19
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYPQA2024-04-02
00382904439255BD Molecular Swab Collection KitBECTON, DICKINSON AND COMPANYPQA2024-02-26
30382904439256BD Molecular Swab Collection KitBECTON, DICKINSON AND COMPANYPQA2024-02-26
07332940008345Xpert®CEPHEIDPQA2022-04-12
15420045512023Aptima®Hologic, Inc.PQA2019-07-02
15420045512030Aptima®Hologic, Inc.PQA2019-07-02
15420045512047Aptima®Hologic, Inc.PQA2019-07-02
15420045512054Aptima®Hologic, Inc.PQA2019-07-02
15420045512061Aptima®Hologic, Inc.PQA2019-07-02
15420045512078Aptima®Hologic, Inc.PQA2019-07-02
15420045512085Aptima®Hologic, Inc.PQA2019-07-02
15420045512092Aptima®Hologic, Inc.PQA2019-07-02
00382904437121BD MAX™ Vaginal PanelBECTON, DICKINSON AND COMPANYPQA2017-03-23