FDA.reportPublic FDA data

GeneXpert®

Primary DI
07332940008604
Brand
GeneXpert®
Company
CEPHEID
Model
XPRS4PLEX-10
Catalog number
XPRS4PLEX-10
Device description
Xpert Xpress CoV-2/Flu/RSV plus
Published
2023-09-25
Public version status
New
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
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940008604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940008604073329400086047332940008604

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type respiratory 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 (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.

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
18888383222techsupport@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
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
07332940007690GeneXpert®GX-IV R2GX-IV R22022-05-03
07332940007706GeneXpert®GX-XVI R2GX-XVI R22022-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819704020685FINDERBaebies, Inc.QOF2026-10-01
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00850025770156Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 10)Autonomous Medical Devices IncorporatedQOF2026-08-26
00819704020074FINDER InstrumentBaebies, Inc.QOF2026-05-01
00819704020425FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.QOF2026-05-01
00819704020463FINDER Cleaning AccessoryBaebies, Inc.QOF2026-05-01
00819704020487FINDER RVP BufferBaebies, Inc.QOF2026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control SwabBaebies, Inc.QOF2026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control SwabBaebies, Inc.QOF2026-05-01
05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
05061098480032NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007541cobas® Respiratory 4-flexRoche Molecular Systems, Inc.QOF2026-02-24
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCQOF2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCQOF2026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCQOF2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
14053228039409QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
00884999049369Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049376Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049383Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00875197006285cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007299cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007305cobas liat SARS-CoV-2, Influenza A/B & RSV control kitRoche Molecular Systems, Inc.QOF2025-05-28
00810031720019Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10810031720016Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17