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.
Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge - 20-006-001
Device Description
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.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OMM
Device Name: Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
Device Class: 2
Physical State: genotyping test system
Definition: In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia.
Submission Type ID: 1
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses DNA genotyping technology to determine patient genotype at the 5, 10-methylenetetrahydrofolate reductase gene locus.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: clinical samples (blood, saliva, buccal swab samples)
Regulation Number: 864.7280
Third Party Flag: Y
Medical Specialty: HE
Code: NPQ
Device Name: Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device Class: 2
Physical State: N/A
Definition: In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Submission Type ID: 1
Review Panel: PA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.7280
Third Party Flag: N
Medical Specialty: HE
Code: NPR
Device Name: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Device Class: 2
Physical State: N/A
Definition: In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Submission Type ID: 1
Review Panel: PA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.7280
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 00857573006027
Device Type: Previous
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 00840487101513
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A