| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 15420045515031 | 2050-0104 | 2050-0104 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
| 2 | 15420045514089 | R15 | R15 | GDF | GUIDE, NEEDLE, SURGICAL | 1 | PERL | |
| 3 | 15420045506909 | Discovery C | KGI | Densitometer, bone | 2 | Discovey C | ||
| 4 | 15420045504110 | ATEC Sapphire 200 | KNW | INSTRUMENT, BIOPSY | 2 | ATEC Sapphire 200 | ||
| 5 | 15420045510333 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
| 6 | 15420045514294 | V5 | NSV5US-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 7 | 25420045510330 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
| 8 | 25420045514307 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 9 | 25420045505107 | 40-902 | 40-902 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
| 10 | 15420045514836 | PATHVISION 23x29 | PATHVISION23X29 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
| 11 | 15420045514300 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 12 | 15420045512924 | INTERNAL CONTROL-B, 960T, IVD | PRD-06234 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
| 13 | 15420045512917 | EXTRACTION REAGENTS-B, 960T, IVD | PRD-06232 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
| 14 | 15420045510906 | GBS CTRLS KIT, PANTHER FUSION, IVD | PRD-04485 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 15 | 15420045510890 | GBS KIT, 96T, IVD | PRD-04484 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 16 | 15420045510470 | INTERNAL CONTROL-X, 960T, IVD | PRD-04476 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 17 | 15420045510463 | EXTRACTION REAGENT-X, 960T, IVD | PRD-04477 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 18 | 15420045509641 | System Software | InSight FD | OXO | Image-intensified fluoroscopic x-ray system, mobile | 2 | Flouroscan InSight | |
| 19 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | aptima | |
| 20 | 15420045507937 | 20-401ML | 20-401ML | NWW | Hysteroscope accessories | Myosure Manual Tissue Removal Device | ||
| 21 | 15420045505230 | B90003 | B90003 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4.0-5.0 CM CT LUMEN MARKER SET | |
| 22 | 15420045505193 | B11245 | B11245 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER | |
| 23 | 15420045505094 | 50-501XL | 50-501XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 24 | 15420045505087 | 50-401XL | 50-401XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
| 25 | 15420045505070 | 30-401LITE | 30-401LITE | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 26 | 15420045505001 | 919007-01 | 919007-01 | JAQ | System, applicator, radionuclide, remote-controlled | Mammosite Variable 4-5 cm Applicator Tray | ||
| 27 | 15420045504998 | EVIVA_1213-20 | EVIVA_1213-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_1213-20 | ||
| 28 | 15420045504950 | EVIVA_0910-20 | EVIVA_0910-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_0910-20 | ||
| 29 | 15420045504813 | 10-401 | 10-401 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 30 | 15420045501140 | 2000 | NS2000US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
| 31 | 15420045501133 | 2007 | NS2007US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
| 32 | 15420045501126 | 2013 | NS2013KITUS | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
| 33 | 15420045501119 | 2013 | NS2013US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
| 34 | 15420045501065 | Cervista HTA System Computer | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 35 | 15420045500969 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 36 | 15420045500952 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 37 | 15420045500860 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
| 38 | 15420045500853 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
| 39 | 15420045512474 | GENIUS AI DETECTION SOFTWARE | OTE | Digital breast tomosynthesis | 3 | GENIUS AI DETECTION | ||
| 40 | 25420045510064 | FILTER, THINPREP UROCYTE 100 PACK | 70472-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
| 41 | 25420045510057 | THINPREP SLIDES UROCYTE, 100 pk | 70471-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 42 | 25420045509990 | THINPREP MICROSCOPE, ARCLESS, 72pk | 70126-002 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 43 | 25420045509679 | NON-GYN Slides | 70372-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 44 | 25420045509662 | NON-GYN Filters, 100 pack | 70205-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
| 45 | 25420045508467 | UroCyte Vial | 70473-001 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 46 | 25420045505039 | 819001 | 819001 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Neucletron HDR Afterloader Connectors wObturators | |
| 47 | 15420045514775 | PRESERVCYT VIAL | PRD-07129 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 48 | 15420045514621 | UroCyte Vial | ASY-15509 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 49 | 15420045514614 | CytoLyt Cup | PRD-07065 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 50 | 15420045514607 | CytoLyt Tube | PRD-07064 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 15420045506701 | INVADER FACTOR V, 1680 TESTS | 95-457 | None | INVADER | HOLOGIC, INC. |
| 2 | 15420045506664 | INVADER FACTOR V, 144 TESTS | 95-453 | None | INVADER | HOLOGIC, INC. |
| 3 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | Xpert HemosIL FII & FV | CEPHEID |
| 4 | 07332940000240 | GXFIIFV-10 | GXFIIFV-10 | Xpert Factor II & Factor V kit; 10 test kit | Xpert Factor II & Factor V | CEPHEID |
| 5 | 04038377021591 | 1 | 04618955001 | Factor II Prothrombin G20210A Kit | ROCHE DIAGNOSTICS GMBH | |
| 6 | 00875197005998 | 07948352190 | 07948352190 | cobas Factor II and Factor V Test | ROCHE MOLECULAR SYSTEMS, INC. | |
| 7 | 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. | |
| 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 | 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 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |