Home GUDID 04038377021607 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 Code Name NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04038377021607 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04038377021607 04038377021607 4038377021607
GMDN Terms# Term, Definition table Term Definition 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).
Regulatory Flags# DUNS number 315028860 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840487101513 Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge LUMINEX CORPORATION NPQ 2019-12-05 00840487101728 Hypercoagulation Panel (HC) Sample Buffer LUMINEX CORPORATION NPQ 2019-12-05 00850009370075 INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine AUTOGENOMICS, INC NPQ 2019-10-23 00850009370082 INFINITI® Factor V Leiden Intellipac® Reagent Module AUTOGENOMICS, INC NPQ 2019-10-23 00850009370099 INFINITI® Factor V Leiden Amplification Mix AUTOGENOMICS, INC NPQ 2019-10-23 00850009370105 INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine AUTOGENOMICS, INC NPQ 2019-10-23 00850009370112 INFINITI® Factor II-V Leiden Intellipac® Reagent Module AUTOGENOMICS, INC NPQ 2019-10-23 00850009370129 INFINITI® Factor II-V Leiden Amplification Mix AUTOGENOMICS, INC NPQ 2019-10-23 00875197005998 cobas Factor II and Factor V Test Roche Molecular Systems, Inc. NPQ 2018-02-14 07332940000240 Xpert Factor II & Factor V CEPHEID NPQ 2018-01-29 07332940000936 Xpert HemosIL FII & FV CEPHEID NPQ 2018-01-29 00857573006027 Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge NANOSPHERE, INC. NPQ 2016-09-23 00857573006348 Hypercoagulation Panel (HC) Sample Buffer NANOSPHERE, INC. NPQ 2016-09-23 15420045506558 INVADER Hologic, Inc. NPQ 2016-08-29 15420045506695 INVADER Hologic, Inc. NPQ 2016-08-29