FDA.reportPublic FDA data

Xpert SA Nasal Complete

Primary DI
07332940000158
Brand
Xpert SA Nasal Complete
Company
CEPHEID
Model
GXSACOMP-10
Catalog number
GXSACOMP-10
Device description
Xpert SA Nasal Complete 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
NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100822000
K243070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100822000XPERT MRSA/SA NASAL ASSAYCepheid2010-06-01NQX
K243070000Xpert® SA Nasal CompleteCepheid®2024-10-25NQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940000158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940000158073329400001587332940000158

GMDN Terms#

Term, Definition table
TermDefinition
MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique (NAT).

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
1888 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
00840487101575Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONNQX2019-12-05
00840487101629Gram-Positive Blood Culture (BC-GP) Extraction TrayLUMINEX CORPORATIONNQX2019-12-05
00840487101674Gram-Positive Blood Culture (BC-GP) Utility TrayLUMINEX CORPORATIONNQX2019-12-05
00840487101445ARIES® MRSA AssayLUMINEX CORPORATIONNQX2019-10-08
07332940000141Xpert MRSA/SA Blood CultureCEPHEIDNQX2018-01-29
07332940000165Xpert SA Nasal CompleteCEPHEIDNQX2018-01-29
07332940000189Xpert MRSA/SA SSTICEPHEIDNQX2018-01-29
07332940000196Xpert MRSACEPHEIDNQX2018-01-29
07332940001711Xpert MRSA NxGCEPHEIDNQX2018-01-29
07332940001728Xpert MRSA NxGCEPHEIDNQX2018-01-29
07332940002442Xpert MRSACEPHEIDNQX2018-01-29
00382904434199BD MAX™ StaphSRBECTON, DICKINSON AND COMPANYNQX2017-04-12
00382904434618BD MAX™ MRSA XTBECTON, DICKINSON AND COMPANYNQX2017-04-12
03661540950001MRSA/SA ELITe MGBElitechgroup Mdx LLCNQX2016-10-13
00857573006119Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeNANOSPHERE, INC.NQX2016-09-23
00857573006218Gram-Positive Blood Culture (BC-GP) Extraction TrayNANOSPHERE, INC.NQX2016-09-23
00857573006287Gram-Positive Blood Culture (BC-GP) Utility TrayNANOSPHERE, INC.NQX2016-09-23
00382904414481BD GeneOhm™ StaphSR assay 48 TestsAGeneohm Sciences Canada IncNQX2016-08-10
00382904416386BD GeneOhm™ MRSA ACP Lysis KitGeneohm Sciences Canada IncNQX2016-08-10
00382904416379BD GeneOhm™ MRSA ACP Assay (48 tests)Geneohm Sciences Canada IncNQX2016-08-09
00382904416393BD GeneOhm™ MRSA ACP AssayGeneohm Sciences Canada IncNQX2016-08-09
00382904429539BD MAX™ MRSAGeneohm Sciences Canada IncNQX2016-07-27
00382904419165BD MAX™ SystemBECTON, DICKINSON AND COMPANYNQX2016-05-19
00875197002973LightCycler® MRSA Advanced TestRoche Molecular Systems, Inc.NQX2016-03-31
00875197002997LightCycler® Advanced LysisRoche Molecular Systems, Inc.NQX2016-03-31
00875197004410cobas® MRSA/SA TestRoche Molecular Systems, Inc.NQX2016-03-31
00875197004427cobas® MRSA/SA TestRoche Molecular Systems, Inc.NQX2016-03-31
00875197004441cobas® MRSA/SA Controls and Cofactor KitRoche Molecular Systems, Inc.NQX2016-03-31