Xpert HemosIL FII & FV

Primary DI
07332940000936
Brand
Xpert HemosIL FII & FV
Company
CEPHEID
Model
GXHEMOSIL-10
Catalog number
GXHEMOSIL-10
Device description
Xpert HemosIL FII & FV 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
NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr
NPRTest, Factor Ii G20210a Mutations, Genomic Dna Pcr

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPQTest, Factor V Leiden Mutations, Genomic Dna PcrHematology2
NPRTest, Factor Ii G20210a Mutations, Genomic Dna PcrHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082118000XPERT HEMOSIL FACTOR II & FACTOR V ASSAYCepheid2009-09-18NPQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940000936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940000936073329400009367332940000936

GMDN Terms#

Term, Definition table
TermDefinition
Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), 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
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
07332940009519GeneXpert® CEPHEIDNPR2025-11-21
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00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATIONNPR2019-12-05
00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATIONNPQ2019-12-05
00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATIONNPR2019-12-05
00850009370044INFINITI® Factor II BioFilmChip® Microarray MagazineAUTOGENOMICS, INCNPR2019-10-23
00850009370051INFINITI® Factor II Intellipac® Reagent ModuleAUTOGENOMICS, INCNPR2019-10-23
00850009370068INFINITI® Factor II Amplification MixAUTOGENOMICS, INCNPR2019-10-23
00850009370075INFINITI® Factor V Leiden BioFilmChip® Microarray MagazineAUTOGENOMICS, INCNPQ2019-10-23
00850009370082INFINITI® Factor V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPQ2019-10-23
00850009370099INFINITI® Factor V Leiden Amplification MixAUTOGENOMICS, INCNPQ2019-10-23
00850009370105INFINITI® Factor II-V Leiden BioFilmChip® Microarray MagazineAUTOGENOMICS, INCNPR2019-10-23
00850009370105INFINITI® Factor II-V Leiden BioFilmChip® Microarray MagazineAUTOGENOMICS, INCNPQ2019-10-23
00850009370112INFINITI® Factor II-V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPR2019-10-23
00850009370112INFINITI® Factor II-V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPQ2019-10-23
00850009370129INFINITI® Factor II-V Leiden Amplification MixAUTOGENOMICS, INCNPR2019-10-23
00850009370129INFINITI® Factor II-V Leiden Amplification MixAUTOGENOMICS, INCNPQ2019-10-23
00875197005998cobas Factor II and Factor V TestRoche Molecular Systems, Inc.NPR2018-02-14
00875197005998cobas Factor II and Factor V TestRoche Molecular Systems, Inc.NPQ2018-02-14
07332940000240Xpert Factor II & Factor VCEPHEIDNPQ2018-01-29
07332940000240Xpert Factor II & Factor VCEPHEIDNPR2018-01-29
04038377021607Factor V Leiden KitRoche Diagnostics GmbHNPQ2016-09-23
00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeNANOSPHERE, INC.NPQ2016-09-23
00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeNANOSPHERE, INC.NPR2016-09-23
00857573006348Hypercoagulation Panel (HC) Sample BufferNANOSPHERE, INC.NPR2016-09-23
00857573006348Hypercoagulation Panel (HC) Sample BufferNANOSPHERE, INC.NPQ2016-09-23
15420045506558INVADERHologic, Inc.NPQ2016-08-29
15420045506664INVADERHologic, Inc.NPR2016-08-29
15420045506695INVADERHologic, Inc.NPQ2016-08-29
15420045506701INVADERHologic, Inc.NPR2016-08-29