FDA.reportPublic FDA data

Hypercoagulation Panel (HC) Sample Buffer

Primary DI
00840487101728
Brand
Hypercoagulation Panel (HC) Sample Buffer
Company
LUMINEX CORPORATION
Model
30-001-001
Catalog number
30-001-001
Device description
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
Published
2019-12-05
Public version status
Update
Distribution status
Not 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
OMMTest 5, 10-methylenetetrahydrofolate reductase 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
OMMTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna PcrHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857573006348PreviousGS10
00840487101728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857573006348008575730063488575730063480857573006348
00840487101728008404871017288404871017280840487101728

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen, using a clotting method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)785-2323support@luminexcorp.com

Regulatory Flags#

DUNS number
080778937
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-00120-006-0012019-12-05
00840487101858LIAISON PLEX Gram-Positive Blood Culture Assay20-005-30520-005-3052025-07-11
00840487101865LIAISON PLEX Yeast Blood Culture Assay Kit20-005-30620-005-3062024-10-22
00840487101940LIAISON PLEX® Respiratory Flex Assay Kit20-005-32220-005-3222024-06-20
00840487101841LIAISON PLEX Gram-Negative Blood Culture Assay20-005-30320-005-3032025-06-11
00840487100127MHV Control Primers 5380638062016-12-16
00840487100233MultiCode® Chlamydophila pneumoniae Primers392539252016-12-16
00840487100240MultiCode® Legionella pneumophila Primers392639262016-12-16
00840487100257MultiCode® Mycoplasma pneumoniae Primers392739272016-12-16
00840487101049MHV DNA Sample Processing Control370037002016-12-16
00840487101056MHV DNA Sample Processing Control3700-023700-022016-12-16
00840487101063MHV DNA Sample Processing Control3700-213700-212016-12-16
00840487101070MHV DNA Sample Processing Control3700-223700-222016-12-16
00840487101087MHV DNA Sample Processing Control371037102016-12-16
00840487101100MHV DNA Amplification Control369436942016-12-16
00840487101155MHV Control Primers 1380238022016-12-16
00840487101179MHV Control Primers 2380338032016-12-16
00840487101186MHV Control Primers 23803-213803-212016-12-16
00840487101193MHV Control Primers 3380438042016-12-16
00840487101216MHV Control Primers 33804-223804-222016-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332940009519GeneXpert® CEPHEIDNPR2025-11-21
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATIONNPQ2019-12-05
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOMM2019-12-05
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX 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, INCNPQ2019-10-23
00850009370105INFINITI® Factor II-V Leiden BioFilmChip® Microarray MagazineAUTOGENOMICS, INCNPR2019-10-23
00850009370112INFINITI® Factor II-V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPQ2019-10-23
00850009370112INFINITI® Factor II-V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPR2019-10-23
00850009370129INFINITI® Factor II-V Leiden Amplification MixAUTOGENOMICS, INCNPQ2019-10-23
00850009370129INFINITI® Factor II-V Leiden Amplification MixAUTOGENOMICS, INCNPR2019-10-23
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
07332940000936Xpert HemosIL FII & FVCEPHEIDNPR2018-01-29
07332940000936Xpert HemosIL FII & FVCEPHEIDNPQ2018-01-29
04038377021607Factor V Leiden KitRoche Diagnostics GmbHNPQ2016-09-23
00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeNANOSPHERE, INC.OMM2016-09-23
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
00857573006348Hypercoagulation Panel (HC) Sample BufferNANOSPHERE, INC.OMM2016-09-23
15420045506725INVADERHologic, Inc.OMM2016-09-08