No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00875197006254 | 08688214190 | 08688214190 | QLX | Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA | 2 | cobas® EBV/BKV Control Kit | |
2 | 00875197005646 | 07402678190 | 07402678190 | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | cobas® Strep A Quality Control Kit for use on the cobas® Liat® System | |
3 | 00875197005363 | 2.0 | 07102577190 | OOI,LSL,MKZ | real time Nucleic acid amplification system,DNA-REAGENTS, NEISSERIA,DNA PROBE, N real time Nucleic acid amplification system,DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | cobas® 4800 CT/NG Test v2.0 | |
4 | 00875197005356 | 2.0 | 07102569190 | LSL,MKZ,OOI | DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,real ti DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,real time Nucleic acid amplification system | 1 | cobas® 4800 CT/NG Test v2.0 | |
5 | 00875197004458 | 1.0 | 06768318190 | OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 2 | cobas® 4800 Systems Internal Control Kit | |
6 | 00875197004427 | 1.0 | 06768172190 | NQX,OOI | SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN,real time Nucleic acid amplification system | 2 | cobas® MRSA/SA Test | |
7 | 00875197004410 | 1.0 | 06768113190 | OOI,NQX | real time Nucleic acid amplification system,SYSTEM, NUCLEIC ACID AMPLIFICATION T real time Nucleic acid amplification system,SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN | 2 | cobas® MRSA/SA Test | |
8 | 00875197004120 | 05985536190 | 05985536190 | OWD | Somatic gene mutation detection system | 3 | cobas® DNA Sample Preparation Kit | |
9 | 00875197003215 | 1.0 | 05235847190 | LSL,OOI,MKZ | DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system,DNA PROBE, N DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | cobas® 4800 System Control Diluent Kit | |
10 | 00875197003185 | 05235804190 | 05235804190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 System Sample Preparation Kit | |
11 | 00875197003178 | 05235782190 | 05235782190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 System Sample Preparation Kit | |
12 | 00875197001983 | 03568555190 | 03568555190 | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test | |
13 | 00875197001068 | 2 | 03302563018 | COBAS® AmpliScreen HCV Test, v2.0 | ||||
14 | 00875197000993 | 2 | 03155935018 | MTL | MONITOR,TEST,HIV-1 | 3 | COBAS AMPLICOR HIV-1 Monitor Test, version 1.5 | |
15 | 08430215046203 | 03531414001 | 03531414001 | OOI | real time Nucleic acid amplification system | 2 | LightCycler® 2.0 Instrument | |
16 | 07613336171295 | 08988218001 | 08988218001 | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | cobas® prime Secondary Tube Tray | |
17 | 07613336146644 | 08106568001 | 08106568001 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | AVENIO Millisect | |
18 | 04015630925537 | 03121453001 | 03121453001 | JJF | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE | 1 | COBAS® TaqMan® | |
19 | 00875197006421 | 09040897190 | 09040897190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas® CMV | |
20 | 00875197006131 | 08244049190 | 08244049190 | cobas Babesia | ||||
21 | 00875197005776 | 07460066190 | 07460066190 | MKZ,LSL,OOI | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA,real ti DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system | 1 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | |
22 | 00875197005752 | 07460155190 | 07460155190 | MAQ | Kit, Dna Detection, Human Papillomavirus | 3 | cobas HPV for use on the cobas 6800/8800 systems | |
23 | 00875197004939 | 07001037190 | 07001037190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas CMV Control Kit | |
24 | 00875197004069 | 2 | 05923450190 | MZF | Test, hiv detection | 2 | COBAS® TaqMan® HIV-1 Test version 2.0, For Use With the High Pure System | |
25 | 00875197004045 | 2.0 | 05969484190 | cobas® TaqScreen MPX Test, v2.0 | ||||
26 | 00875197003260 | 05235898190 | 05235898190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 HPV Amplification/Detection Kit | |
27 | 00875197003253 | 05235880190 | 05235880190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 HPV Amplification/Detection Kit | |
28 | 00875197003024 | 2 | 05212308190 | MZF | Test, hiv detection | 2 | COBAS® AmpliPrep/ COBAS® TaqMan® HIV- 1 Test, version 2.0 | |
29 | 00875197002676 | 05002125190 | 05002125190 | cobas® TaqScreen Cadaveric Specimen Diluent Kit | ||||
30 | 00875197002218 | 04404220190 | 04404220190 | cobas® TaqScreen Wash Reagent | ||||
31 | 00875197002003 | 03577163190 | 03577163190 | MKT | Hepatitis Viral B DNA Detection | 3 | COBAS® TaqMan® HBV Test, For Use With The High Pure System | |
32 | 00875197001099 | 2 | 03322114018 | COBAS® AmpliScreen HIV-1 Test, v1.5 | ||||
33 | 00875197000030 | 20759899123 | 20759899123 | COBAS® AMPLICOR Wash Buffer | ||||
34 | 07613336193297 | 09341935001 | 09341935001 | GWW | Ataxiagraph | 1 | Floodlight MS Draw Shape Test | |
35 | 07613336193280 | 09341927001 | 09341927001 | GWW | Ataxiagraph | 1 | Floodlight MS Draw Shape Test | |
36 | 07613336193259 | 09341889001 | 09341889001 | GWW | Ataxiagraph | 1 | Floodlight MS Pinching Test | |
37 | 07613336119563 | 07886977001 | 07886977001 | OOI | real time Nucleic acid amplification system | 2 | cobas Liat Software Version 3.0 | |
38 | 04038377020556 | 03502295001 | 03502295001 | MKT | Hepatitis Viral B DNA Detection | 3 | High Pure System Viral Nucleic Acid Kit | |
39 | 00875197006490 | 09040919190 | 09040919190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas® CMV Control Kit | |
40 | 00875197006483 | 09040536190 | 09040536190 | MZF | Test, HIV detection | 2 | cobas® HIV-1/HIV- 2 192T | |
41 | 00875197006445 | 09051554190 | 09051554190 | MZF | Test, HIV detection | 2 | cobas® NHP Negative Control Kit | |
42 | 00875197006261 | 08688206190 | 08688206190 | QLX | Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA | 2 | cobas® EBV | |
43 | 00875197005264 | 1.0 | 06768253190 | OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 2 | cobas® 4800 System Lysis Kit | |
44 | 00875197004229 | 06471463190 | 06471463190 | OWD | Somatic gene mutation detection system | 3 | cobas® EGFR Mutation Test | |
45 | 00875197004182 | 2 | 05989060190 | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | COBAS® TaqMan® HCV Test For Use With the High Pure System | |
46 | 00875197004137 | 05985579190 | 05985579190 | OWD | Somatic gene mutation detection system | 3 | cobas® 4800 BRAF V600 Mutation Test | |
47 | 00875197002102 | 03599779190 | 03599779190 | COBAS® AmpliScreen HBV Test | ||||
48 | 00875197001051 | 03302555018 | 03302555018 | COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit | ||||
49 | 07613336193273 | 09341919001 | 09341919001 | PTY | Computerized Cognitive Assessment Aid, Exempt | 2 | Floodlight MS Cognitive Test | |
50 | 07613336193266 | 09341897001 | 09341897001 | PTY | Computerized Cognitive Assessment Aid, Exempt | 2 | Floodlight MS Cognitive Test |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00875197005998 | 07948352190 | 07948352190 | cobas Factor II and Factor V Test | ROCHE MOLECULAR SYSTEMS, INC. | |
2 | 00875197005998 | 07948352190 | 07948352190 | cobas Factor II and Factor V Test | ROCHE MOLECULAR SYSTEMS, INC. | |
3 | 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. | |
4 | 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. | |
5 | 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. | |
6 | 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. | |
7 | 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 |
8 | 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 |
9 | 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 |
10 | 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 |
11 | 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 |
12 | 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 |
13 | 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 |
14 | 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 |
15 | 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 |
16 | 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 |
17 | 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 |
18 | 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 |
19 | 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 |
20 | 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 |
21 | 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 |
22 | 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 |
23 | 15420045506701 | INVADER FACTOR V, 1680 TESTS | 95-457 | None | INVADER | HOLOGIC, INC. |
24 | 15420045506695 | INVADER FACTOR II, 1680 TESTS | 95-456 | INVADER | HOLOGIC, INC. | |
25 | 15420045506664 | INVADER FACTOR V, 144 TESTS | 95-453 | None | INVADER | HOLOGIC, INC. |
26 | 15420045506558 | INVADER FACTOR II, 144 TESTS | 95-452 | INVADER | HOLOGIC, INC. | |
27 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | Xpert HemosIL FII & FV | CEPHEID |
28 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | Xpert HemosIL FII & FV | CEPHEID |
29 | 07332940000240 | GXFIIFV-10 | GXFIIFV-10 | Xpert Factor II & Factor V kit; 10 test kit | Xpert Factor II & Factor V | CEPHEID |
30 | 07332940000240 | GXFIIFV-10 | GXFIIFV-10 | Xpert Factor II & Factor V kit; 10 test kit | Xpert Factor II & Factor V | CEPHEID |
31 | 04038377021607 | 1 | 04618777001 | Factor V Leiden Kit | ROCHE DIAGNOSTICS GMBH | |
32 | 04038377021591 | 1 | 04618955001 | Factor II Prothrombin G20210A Kit | ROCHE DIAGNOSTICS GMBH |