Device Description : The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications.
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications.
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® 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 Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualita The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed us The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
Device Class : 2
Duns Number: 164757242
Premarket Exempt : No
Prescription Use : Yes