No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 07332940003821 | INFINITY 80-24 | 900-0496 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
2 | 07332940003937 | GXIV-1-R | 900-0510R | OOI | Real Time Nucleic Acid Amplification System | 2 | Certified Pre-Owned GeneXpert Dx System | |
3 | 07332940003838 | INFINITY 80-16 | 900-0495 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
4 | 07332940003814 | INFINITY 80-32 | 900-0497 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
5 | 07332940003975 | INFINITY 80-72 | 900-0502 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
6 | 07332940003968 | INFINITY 80-80 | 900-0503 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
7 | 07332940006860 | INFINITY 48-48 | 900-0457 | XPERT, GENEXPERT DX SYSTEM | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System |
8 | 07332940006853 | INFINITY 48-40 | 900-0456 | Additional catalog number: 900-0456R | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System |
9 | 07332940006846 | INFINITY 48-32 | 900-0455 | Additional catalog number: 900-0455R | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System |
10 | 07332940006839 | INFINITY 48-24 | 900-0454 | Additional catalog number: 900-0454R | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System |
11 | 07332940004002 | INFINITY 80-48 | 900-0499 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
12 | 07332940004019 | INFINITY 80-40 | 900-0498 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
13 | 07332940003999 | INFINITY 80-56 | 900-0500 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
14 | 07332940003982 | INFINITY 80-64 | 900-0501 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
15 | 07332940003449 | GXIV-4 | 900-0065 | XPERT, GENEXPERT DX SYSTEM | OOI,NJR | Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay Sys Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | GeneXpert Dx System |
16 | 07332940002558 | SWAB/A-50 | SWAB/A-50 | Xpert Vaginal/Endocervical Specimen Collection Kit; 50 pack | LIO | Device, Specimen Collection | 1 | Xpert Vaginal/Endocervical Specimen Collection Kit |
17 | 07332940001032 | GXCARBAR-10 | GXCARBAR-10 | Xpert Carba-R test; 10 test kit | POC,PMY | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, D System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen,System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | Xpert Carba-R |
18 | 07332940007669 | GXGBSLBXC | GXGBSLBXC-120 | GBS LB XC | NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Xpert® |
19 | 07332940007652 | GXGBSLBXC | GXGBSLBXC-10 | GBS LB XC | NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Xpert® |
20 | 07332940008345 | SWAB/G-50-US | SWAB/G-50-US | Swab Specimen Collection Kit | PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 2 | Xpert® |
21 | 07332940007072 | XPRSMVP-10 | XPRSMVP-10 | Xpert Xpress MVP | PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 2 | Xpert® |
22 | 07332940007003 | SWAB/G-50 | SWAB/G-50 | Xpert Swab Specimen Collection Kit; 50 pack | QBD | Microbial Nucleic Acid Storage And Stabilization Device | 2 | Xpert Swab Specimen Collection Kit |
23 | 07332940006457 | SWAB/F-100 | SWAB/F-100 | Nasal Sample Collect Kit for Viruses | JSM | Culture Media, Non-Propagating Transport | 1 | Xpert® |
24 | 07332940002954 | URINE/A-50 | URINE/A-50 | Xpert Urine Specimen Collection Kit; 50 pack | LIO | Device, Specimen Collection | 1 | Xpert Urine Specimen Collection Kit |
25 | 07332940006044 | XPRSFLU-10 | XPRSFLU-10 | Xpert Xpress Flu kit; 10 test kit | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Xpert Xpress Flu |
26 | 07332940001001 | GXTV-10 | GXTV-10 | Xpert TV kit; 10 test kit | OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 2 | Xpert TV |
27 | 07332940000974 | GXNOV-10 | GXNOV-10 | Xpert Norovirus kit; 10 test kit | PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | Xpert Norovirus |
28 | 07332940000097 | GXEV-100N-10 | GXEV-100N-10 | Xpert EV kit; 10 test kit | OAI | Assay, Enterovirus Nucleic Acid | 2 | Xpert EV |
29 | 07332940005696 | XPRSFLU/RSV-10 | XPRSFLU/RSV-10 | Xpert Xpress Flu/RSV kit; 10 test kit | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Xpert Xpress Flu/RSV |
30 | 07332940000783 | GXFLU/RSV-10 | GXFLU/RSV-10 | Xpert FLU/RSV XC kit; 10 test kit | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Xpert FLU/RSV XC |
31 | 07332940004347 | INFINITY48-24 | 900-0537 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System | |
32 | 07332940004330 | INFINITY 48-32 | 900-0538 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System | |
33 | 07332940004323 | INFINITY 48-40 | 900-0539 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System | |
34 | 07332940004354 | INFINITY48-16 | 900-0536 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System | |
35 | 07332940004316 | INFINITY 48-48 | 900-0540 | Additional catalog numbers: 900-0540L, 900-0540R | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System |
36 | 07332940002565 | SWAB/B-100 | SWAB/B-100 | Xpert Nasopharyngeal Sample Collection Kit; 100 pack | JSM | Culture Media, Non-Propagating Transport | 1 | Xpert Nasopharyngeal Sample Collection Kit |
37 | 07332940002442 | GXMRSA-120 | GXMRSA-120 | Xpert MRSA kit; 120 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA |
38 | 07332940001728 | GXMRSA-NXG-120 | GXMRSA-NXG-120 | Xpert MRSA NxG kit: 120 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA NxG |
39 | 07332940001711 | GXMRSA-NXG-10 | GXMRSA-NXG-10 | Xpert MRSA NxG kit; 10 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA NxG |
40 | 07332940000196 | GXMRSA-100N-10 | GXMRSA-100N-10 | Xpert MRSA kit; 10 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA |
41 | 07332940000189 | GXMRSA/SA-SSTI-10 | GXMRSA/SA-SSTI-10 | Xpert MRSA/SA SSTI kit; 10 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA/SA SSTI |
42 | 07332940000141 | GXMRSA/SA-BC-10 | GXMRSA/SA-BC-10 | Xpert MRSA/SA Blood Culture kit; 10 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA/SA Blood Culture |
43 | 07332940000059 | GXCDIFFICILE-120 | GXCDIFFICILE-120 | Xpert C. difficile test; 120 test kit | LLH | Reagents, Clostridium Difficile Toxin | 1 | Xpert C. difficile |
44 | 07332940000035 | GXCDIFFICILE-10 | GXCDIFFICILE-10 | Xpert C. difficile test; 10 test kit | LLH | Reagents, Clostridium Difficile Toxin | 1 | Xpert C. difficile |
45 | 07332940006372 | XPRSTREPA-10 | XPRSTREPA-10 | Xpert Xpress Strep A kit; 10 test kit | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Xpert Xpress Strep A |
46 | 07332940002503 | XPRSTREPA-120 | XPRSTREPA-120 | Xpert Xpress Strep A kit; 120 test kit | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Xpert Xpress Strep A |
47 | 07332940000882 | GXGBS-LB-10 | GXGBS-LB-10 | Xpert GBS LB kit; 10 test kit | NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Xpert GBS LB |
48 | 07332940000806 | GXGBS-LB-120 | GXGBS-LB-120 | Xpert GBS LB kit; 120 test kit | NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Xpert GBS LB |
49 | 07332940007690 | GX-IV R2 | GX-IV R2 | XPERT, GENEXPERT DX SYSTEM | OOI,NJR | Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay Sys Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | GeneXpert® |
50 | 07332940007195 | GXIV-HUB | 900-0828 | Xpress System | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert® |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04038377021607 | 1 | 04618777001 | Factor V Leiden Kit | ROCHE DIAGNOSTICS GMBH | |
2 | 04038377021591 | 1 | 04618955001 | Factor II Prothrombin G20210A Kit | ROCHE DIAGNOSTICS GMBH | |
3 | 00875197005998 | 07948352190 | 07948352190 | cobas Factor II and Factor V Test | ROCHE MOLECULAR SYSTEMS, INC. | |
4 | 00875197005998 | 07948352190 | 07948352190 | cobas Factor II and Factor V Test | ROCHE MOLECULAR SYSTEMS, INC. | |
5 | 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. | |
6 | 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. | |
7 | 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. | |
8 | 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. | |
9 | 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 |
10 | 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 |
11 | 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 |
12 | 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 |
13 | 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 |
14 | 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 |
15 | 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 |
16 | 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 |
17 | 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 |
18 | 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 |
19 | 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 |
20 | 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 |
21 | 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 |
22 | 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 |
23 | 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 |
24 | 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 |
25 | 15420045506701 | INVADER FACTOR V, 1680 TESTS | 95-457 | None | INVADER | HOLOGIC, INC. |
26 | 15420045506695 | INVADER FACTOR II, 1680 TESTS | 95-456 | INVADER | HOLOGIC, INC. | |
27 | 15420045506664 | INVADER FACTOR V, 144 TESTS | 95-453 | None | INVADER | HOLOGIC, INC. |
28 | 15420045506558 | INVADER FACTOR II, 144 TESTS | 95-452 | INVADER | HOLOGIC, INC. | |
29 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | Xpert HemosIL FII & FV | CEPHEID |
30 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | Xpert HemosIL FII & FV | CEPHEID |
31 | 07332940000240 | GXFIIFV-10 | GXFIIFV-10 | Xpert Factor II & Factor V kit; 10 test kit | Xpert Factor II & Factor V | CEPHEID |
32 | 07332940000240 | GXFIIFV-10 | GXFIIFV-10 | Xpert Factor II & Factor V kit; 10 test kit | Xpert Factor II & Factor V | CEPHEID |