Home GUDID 07332940009519 GeneXpert®
Primary DI 07332940009519
Brand GeneXpert®
Company CEPHEID
Model GXFIIFV-US-10
Catalog number GXFIIFV-US-10
Device description Xpert FII & FV
Published 2025-11-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07332940009519 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07332940009519 07332940009519 7332940009519
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).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 28 Degrees Celsius
Regulatory Flags# DUNS number 956711444 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 NPR 2019-12-05 00840487101728 Hypercoagulation Panel (HC) Sample Buffer LUMINEX CORPORATION NPR 2019-12-05 00850009370044 INFINITI® Factor II BioFilmChip® Microarray Magazine AUTOGENOMICS, INC NPR 2019-10-23 00850009370051 INFINITI® Factor II Intellipac® Reagent Module AUTOGENOMICS, INC NPR 2019-10-23 00850009370068 INFINITI® Factor II Amplification Mix AUTOGENOMICS, INC NPR 2019-10-23 00850009370105 INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine AUTOGENOMICS, INC NPR 2019-10-23 00850009370112 INFINITI® Factor II-V Leiden Intellipac® Reagent Module AUTOGENOMICS, INC NPR 2019-10-23 00850009370129 INFINITI® Factor II-V Leiden Amplification Mix AUTOGENOMICS, INC NPR 2019-10-23 00875197005998 cobas Factor II and Factor V Test Roche Molecular Systems, Inc. NPR 2018-02-14 07332940000240 Xpert Factor II & Factor V CEPHEID NPR 2018-01-29 07332940000936 Xpert HemosIL FII & FV CEPHEID NPR 2018-01-29 00857573006027 Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge NANOSPHERE, INC. NPR 2016-09-23 00857573006348 Hypercoagulation Panel (HC) Sample Buffer NANOSPHERE, INC. NPR 2016-09-23 15420045506664 INVADER Hologic, Inc. NPR 2016-08-29 15420045506701 INVADER Hologic, Inc. NPR 2016-08-29 04038377021591 Factor II Prothrombin G20210A Kit Roche Diagnostics GmbH NPR 2016-03-31
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