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Factor V Leiden Kit

Primary DI
04038377021607
Brand
Factor V Leiden Kit
Company
Roche Diagnostics GmbH
Model
1
Catalog number
04618777001
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038377021607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038377021607040383770216074038377021607

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATIONNPQ2019-12-05
00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATIONNPQ2019-12-05
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, INCNPQ2019-10-23
00850009370112INFINITI® Factor II-V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPQ2019-10-23
00850009370129INFINITI® Factor II-V Leiden Amplification MixAUTOGENOMICS, INCNPQ2019-10-23
00875197005998cobas Factor II and Factor V TestRoche Molecular Systems, Inc.NPQ2018-02-14
07332940000240Xpert Factor II & Factor VCEPHEIDNPQ2018-01-29
07332940000936Xpert HemosIL FII & FVCEPHEIDNPQ2018-01-29
00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeNANOSPHERE, INC.NPQ2016-09-23
00857573006348Hypercoagulation Panel (HC) Sample BufferNANOSPHERE, INC.NPQ2016-09-23
15420045506558INVADERHologic, Inc.NPQ2016-08-29
15420045506695INVADERHologic, Inc.NPQ2016-08-29