Hypercoagulation Panel (HC) Sample Buffer

DI: 00840487101728 · Model: 30-001-001 · LUMINEX CORPORATION

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: Hypercoagulation Panel (HC) Sample Buffer
Primary DI: 00840487101728
Version / Model: 30-001-001
Catalog Number: 30-001-001
Company Name: LUMINEX CORPORATION
Labeler DUNS: 080778937
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2019-12-05
Public Version: 2
Public Version Date: 2021-02-01
Public Version Status: Update
Public Device Record Key: 50b1b1e8-7561-4308-8044-54e1cf528621
Distribution End Date: 2021-01-29

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.

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMM	Test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr	Hematology	864.7280	2
NPQ	TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR	Hematology	864.7280	2
NPR	TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR	Hematology	864.7280	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55996	Multiple coagulation factor IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen, using a clotting method.	No	Active