| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00857573006164 | 20-006-024 | The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. | OZE,OEM,OCC,OEP,OZZ,OOU | Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus ( Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Bordetella Pertussis Dna Assay System,Parainfluenza Multiplex Nucleic Acid Assay | 2 | Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge | |
| 2 | 00857573006089 | 20-011-023 | 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. | PCI,PCH | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastr Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | Enteric Pathogens (EP) Amplification Tray | |
| 3 | 00857573006324 | 20-011-024 | The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. | OZE,OEM,OCC,OEP,OZZ,OOU | Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus ( Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Bordetella Pertussis Dna Assay System,Parainfluenza Multiplex Nucleic Acid Assay | 2 | Respiratory Pathogens Flex (RP Flex) Amplification Tray | |
| 4 | 00857573006232 | 20-009-020 | 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. | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Respiratory Virus Plus (RV+) Extraction Tray | |
| 5 | 00857573006010 | 10-0000-07 | 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. | OOI,NSU | Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multipl Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multiplex Test Systems | 2 | Verigene® Processor SP | |
| 6 | 00857573006393 | 10-0000-02R | 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. (Refurbished) | NSU,OOI | Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Ampli Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Amplification System | 2 | Verigene® Reader (Refurbished) | |
| 7 | 00857573006362 | 30-002-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Clostridium difficile (CDF) Stool Sample Preparation Kit | |
| 8 | 00857573006249 | 20-009-021 | The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed 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. | PEN | Gram-Negative Bacteria And Associated Resistance Markers | 2 | Gram-Negative Blood Culture (BC-GN) Extraction Tray | |
| 9 | 00857573006287 | 20-011-018 | The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed us 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). | NQX,PAM | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen,Gram-Positive Bacteria And Their Resistance Markers | 2 | Gram-Positive Blood Culture (BC-GP) Utility Tray | |
| 10 | 00857573006133 | 20-006-020 | 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. | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge | |
| 11 | 00857573006140 | 20-006-021 | 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. | PEN | Gram-Negative Bacteria And Associated Resistance Markers | 2 | Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge | |
| 12 | 00857573006409 | 10-0000-07R | 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. (Refurbished) | NSU,OOI | Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Ampli Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Amplification System | 2 | Verigene® Processor SP (Refurbished) | |
| 13 | 00857573006348 | 30-001-001 | 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. | NPQ,OMM,NPR | Test, Factor V Leiden Mutations, Genomic Dna Pcr,Test 5, 10-Methylenetetrahydrof Test, Factor V Leiden Mutations, Genomic Dna Pcr,Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr,Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | 2 | Hypercoagulation Panel (HC) Sample Buffer | |
| 14 | 00857573006317 | 20-011-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Clostridium difficile (CDF) Amplification Tray | |
| 15 | 00857573006294 | 20-011-020 | 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. | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Respiratory Virus Plus (RV+) Amplification Tray | |
| 16 | 00857573006058 | 20-009-023 | 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. | PCI,PCH | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastr Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | Enteric Pathogens (EP) Extraction Tray | |
| 17 | 00857573006300 | 20-011-021 | 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. | PEN | Gram-Negative Bacteria And Associated Resistance Markers | 2 | Gram-Negative Blood Culture (BC-GN) Utility Tray | |
| 18 | 00857573006263 | 20-009-024 | The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. | OZE,OEM,OCC,OEP,OZZ,OOU | Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus ( Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Bordetella Pertussis Dna Assay System,Parainfluenza Multiplex Nucleic Acid Assay | 2 | Respiratory Pathogens Flex (RP Flex) Extraction Tray | |
| 19 | 00857573006218 | 20-009-018 | The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed us 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). | NQX,PAM | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen,Gram-Positive Bacteria And Their Resistance Markers | 2 | Gram-Positive Blood Culture (BC-GP) Extraction Tray | |
| 20 | 00857573006003 | 10-0000-02 | 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. | OOI,NSU | Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multipl Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multiplex Test Systems | 2 | Verigene® Reader | |
| 21 | 00857573006386 | 10-0000-04 | The Verigene® Processor is an instrument which internalizes all of the functions The Verigene® Processor is an instrument which internalizes all of the functions required to process a Test Cartridge 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. | NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | Verigene® Processor | |
| 22 | 00857573006256 | 20-009-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Clostridium difficile (CDF) Extraction Tray | |
| 23 | 00857573006157 | 20-006-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative mul The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Clostridium difficile (CDF) Nucleic Acid Test Cartridge | |
| 24 | 00857573006119 | 20-006-018 | 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). | NQX,PAM | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen,Gram-Positive Bacteria And Their Resistance Markers | 2 | Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge | |
| 25 | 00857573006065 | 30-002-023 | 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. | PCI,PCH | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastr Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | Enteric Pathogens (EP) Stool Sample Preparation Kit | |
| 26 | 00857573006041 | 20-006-023 | 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. | PCI,PCH | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastr Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | Enteric Pathogens (EP) Nucleic Acid Test Cartridge |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | Xpert HemosIL FII & FV | CEPHEID |
| 2 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | Xpert HemosIL FII & FV | CEPHEID |
| 3 | 07332940000240 | GXFIIFV-10 | GXFIIFV-10 | Xpert Factor II & Factor V kit; 10 test kit | Xpert Factor II & Factor V | CEPHEID |
| 4 | 07332940000240 | GXFIIFV-10 | GXFIIFV-10 | Xpert Factor II & Factor V kit; 10 test kit | Xpert Factor II & Factor V | CEPHEID |
| 5 | 04038377021607 | 1 | 04618777001 | Factor V Leiden Kit | ROCHE DIAGNOSTICS GMBH | |
| 6 | 04038377021591 | 1 | 04618955001 | Factor II Prothrombin G20210A Kit | ROCHE DIAGNOSTICS GMBH | |
| 7 | 00875197005998 | 07948352190 | 07948352190 | cobas Factor II and Factor V Test | ROCHE MOLECULAR SYSTEMS, INC. | |
| 8 | 00875197005998 | 07948352190 | 07948352190 | cobas Factor II and Factor V Test | ROCHE MOLECULAR SYSTEMS, INC. | |
| 9 | 00857573006348 | 30-001-001 | 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. | Hypercoagulation Panel (HC) Sample Buffer | NANOSPHERE, INC. | |
| 10 | 00857573006348 | 30-001-001 | 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. | Hypercoagulation Panel (HC) Sample Buffer | NANOSPHERE, INC. | |
| 11 | 00857573006348 | 30-001-001 | 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. | Hypercoagulation Panel (HC) Sample Buffer | NANOSPHERE, INC. | |
| 12 | 00857573006027 | 20-006-001 | 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. | Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | |
| 13 | 00857573006027 | 20-006-001 | 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. | Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | |
| 14 | 00857573006027 | 20-006-001 | 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. | Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | |
| 15 | 00850009370129 | 01-3050-01 | 01-3050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | INFINITI® Factor II-V Leiden Amplification Mix | AUTOGENOMICS, INC |
| 16 | 00850009370129 | 01-3050-01 | 01-3050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | INFINITI® Factor II-V Leiden Amplification Mix | AUTOGENOMICS, INC |
| 17 | 00850009370112 | 01-2050-01 | 01-2050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | INFINITI® Factor II-V Leiden Intellipac® Reagent Module | AUTOGENOMICS, INC |
| 18 | 00850009370112 | 01-2050-01 | 01-2050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | INFINITI® Factor II-V Leiden Intellipac® Reagent Module | AUTOGENOMICS, INC |
| 19 | 00850009370105 | 01-1050-01 | 01-1050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine | AUTOGENOMICS, INC |
| 20 | 00850009370105 | 01-1050-01 | 01-1050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine | AUTOGENOMICS, INC |
| 21 | 00850009370099 | 01-3030-01 | 01-3030-01 | Genotyping systme for the detection of the Factor V Leiden G1691A mutation | INFINITI® Factor V Leiden Amplification Mix | AUTOGENOMICS, INC |
| 22 | 00850009370082 | 01-2030-01 | 01-2030-01 | Genotyping system for the detection of the Factor V Leiden G1691A mutation | INFINITI® Factor V Leiden Intellipac® Reagent Module | AUTOGENOMICS, INC |
| 23 | 00850009370075 | 01-1030-01 | 01-1030-01 | Genotyping system for the detection of the Factor V Leiden G1691A mutation | INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine | AUTOGENOMICS, INC |
| 24 | 00850009370068 | 01-3020-01 | 01-3020-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations. | INFINITI® Factor II Amplification Mix | AUTOGENOMICS, INC |
| 25 | 00850009370051 | 01-2020-01 | 01-2020-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A mutation | INFINITI® Factor II Intellipac® Reagent Module | AUTOGENOMICS, INC |
| 26 | 00850009370044 | 01-1020-01 | 01-1020-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations. | INFINITI® Factor II BioFilmChip® Microarray Magazine | AUTOGENOMICS, INC |
| 27 | 00840487101728 | 30-001-001 | 30-001-001 | The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F 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) Sample Buffer | LUMINEX CORPORATION |
| 28 | 00840487101728 | 30-001-001 | 30-001-001 | The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F 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) Sample Buffer | LUMINEX CORPORATION |
| 29 | 00840487101728 | 30-001-001 | 30-001-001 | The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F 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) Sample Buffer | LUMINEX CORPORATION |
| 30 | 00840487101513 | 20-006-001 | 20-006-001 | The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F 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 | LUMINEX CORPORATION |
| 31 | 00840487101513 | 20-006-001 | 20-006-001 | The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F 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 | LUMINEX CORPORATION |
| 32 | 00840487101513 | 20-006-001 | 20-006-001 | The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F 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 | LUMINEX CORPORATION |
| 33 | 15420045506725 | INVADER MTHFR 1298, 1680 TESTS | 95-459 | None | INVADER | HOLOGIC, INC. |
| 34 | 15420045506718 | INVADER MTHFR 677, 1680 TESTS | 95-458 | INVADER | HOLOGIC, INC. | |
| 35 | 15420045506701 | INVADER FACTOR V, 1680 TESTS | 95-457 | None | INVADER | HOLOGIC, INC. |
| 36 | 15420045506695 | INVADER FACTOR II, 1680 TESTS | 95-456 | INVADER | HOLOGIC, INC. | |
| 37 | 15420045506688 | INVADER MTHFR 1298, 144 TESTS | 95-455 | INVADER | HOLOGIC, INC. | |
| 38 | 15420045506671 | INVADER MTHFR 677, 144 TESTS | 95-454 | INVADER | HOLOGIC, INC. | |
| 39 | 15420045506664 | INVADER FACTOR V, 144 TESTS | 95-453 | None | INVADER | HOLOGIC, INC. |
| 40 | 15420045506558 | INVADER FACTOR II, 144 TESTS | 95-452 | INVADER | HOLOGIC, INC. |