Other products from "HOLOGIC, INC."
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 15420045510463 EXTRACTION REAGENT-X, 960T, IVD PRD-04477 NJR Nucleic acid amplification assay system, group b streptococcus, direct specimen test 1 Panther Fusion
17 15420045509641 System Software InSight FD OXO Image-intensified fluoroscopic x-ray system, mobile 2 Flouroscan InSight
18 15420045509375 CLASS I CONTROL - C. ALBICANS PRD-04521 JJX Single (specified) analyte controls (assayed and unassayed) 1 aptima
19 15420045507937 20-401ML 20-401ML NWW Hysteroscope accessories Myosure Manual Tissue Removal Device
20 15420045505230 B90003 B90003 JAQ System, applicator, radionuclide, remote-controlled 2 4.0-5.0 CM CT LUMEN MARKER SET
21 15420045505193 B11245 B11245 JAQ System, applicator, radionuclide, remote-controlled 2 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER
22 15420045505094 50-501XL 50-501XL HIH HYSTEROSCOPE (AND ACCESSORIES) MyoSure Tissue Removal Device
23 15420045505087 50-401XL 50-401XL HIH HYSTEROSCOPE (AND ACCESSORIES) 2 MyoSure Tissue Removal Device
24 15420045505070 30-401LITE 30-401LITE HIH HYSTEROSCOPE (AND ACCESSORIES) MyoSure Tissue Removal Device
25 15420045505001 919007-01 919007-01 JAQ System, applicator, radionuclide, remote-controlled Mammosite Variable 4-5 cm Applicator Tray
26 15420045504998 EVIVA_1213-20 EVIVA_1213-20 KNW INSTRUMENT, BIOPSY EVIVA_1213-20
27 15420045504950 EVIVA_0910-20 EVIVA_0910-20 KNW INSTRUMENT, BIOPSY EVIVA_0910-20
28 15420045504813 10-401 10-401 HIH HYSTEROSCOPE (AND ACCESSORIES) MyoSure Tissue Removal Device
29 15420045501140 2000 NS2000US MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL NovaSure
30 15420045501133 2007 NS2007US MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL NovaSure SureSound
31 15420045501126 2013 NS2013KITUS MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL NovaSure SureSound
32 15420045501119 2013 NS2013US MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL NovaSure
33 15420045501065 Cervista HTA System Computer MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 Cervista HTA System
34 15420045500969 Cervista HTA System MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 Cervista HTA System
35 15420045500952 Cervista HTA System MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 Cervista HTA System
36 15420045500860 NovaSure Controller MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL 3 NovaSure
37 15420045500853 NovaSure Controller MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL 3 NovaSure
38 15420045512474 GENIUS AI DETECTION SOFTWARE OTE Digital breast tomosynthesis 3 GENIUS AI DETECTION
39 25420045510064 FILTER, THINPREP UROCYTE 100 PACK   70472-001 KET FILTERS, CELL COLLECTION, TISSUE PROCESSING ThinPrep
40 25420045510057 THINPREP SLIDES UROCYTE, 100 pk 70471-001 KEW SLIDES, MICROSCOPE ThinPrep
41 25420045509990 THINPREP MICROSCOPE, ARCLESS, 72pk 70126-002 KEW SLIDES, MICROSCOPE ThinPrep
42 25420045509679 NON-GYN Slides 70372-001 KEW SLIDES, MICROSCOPE ThinPrep
43 25420045509662 NON-GYN Filters, 100 pack 70205-001 KET FILTERS, CELL COLLECTION, TISSUE PROCESSING ThinPrep
44 25420045508467 UroCyte Vial 70473-001  LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
45 25420045505039 819001 819001 JAQ System, applicator, radionuclide, remote-controlled 2 Neucletron HDR Afterloader Connectors wObturators
46 15420045514775 PRESERVCYT VIAL PRD-07129 LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
47 15420045514621 UroCyte Vial ASY-15509 LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
48 15420045514614 CytoLyt Cup PRD-07065 LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
49 15420045514607 CytoLyt Tube PRD-07064 LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
50 15420045513655 40-201-30 HIH HYSTEROSCOPE (AND ACCESSORIES) 2 30 Degree Omni Hysteroscope Outflow Channel
Other products with the same Product Code "NJR"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00840733102363 410200 410200 The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM Broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes Automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. it is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Revogene GBS LB MERIDIAN BIOSCIENCE, INC.
2 00840733102196 480350 480350 The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubato The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use. Alethia™ Group B Streptococcus MERIDIAN BIOSCIENCE, INC.
3 00840733102110 479900 479900 The Alethia GBS External Control Kit contains Positive and Negative Control Reag The Alethia GBS External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Group B Streptococcus test kit. External controls are used as part of a routine quality control program. Alethia™ Group B Streptococcus External Control Kit MERIDIAN BIOSCIENCE, INC.
4 00840733101342 280350 280350 The illumigene Group B Streptococcus (GBS) assay, performed on the illumipro-10, The illumigene Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.The illumigene GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. illumigene Group B Streptococcus MERIDIAN BIOSCIENCE, INC.
5 00840733101311 279900 279900 The illumigene GBS External Control Kit contains Positive and Negative Control R The illumigene GBS External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Group B Streptococcus test kit. External controls are used as part of a routine quality control program. illumigene Group B Streptococcus External Control Kit MERIDIAN BIOSCIENCE, INC.
6 00840487100165 50-10021 The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualit The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women. ARIES® GBS Assay LUMINEX CORPORATION
7 00628055344117 410200 410200 The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Revogene® GBS LB MERIDIAN BIOSCIENCE CANADA INC
8 00628055344018 130932 130932 The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The GenePOC GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The GenePOC GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.. GenePOC™ GBS LB GENEPOC INC
9 00382904417727 441772 441772 Kit BD Max GBS BD MAX™ GBS BECTON, DICKINSON AND COMPANY
10 B178GBGBS100 GBGBS-10 GBGBS-10 Group B Strep Assay GREAT BASIN SCIENTIFIC, INC.
11 30014613336440 M311 M311 Solana GBS Assay Solana DIAGNOSTIC HYBRIDS, INC.
12 30014613312024 GBS Assay M202 AmpliVue GBS Assay AmpliVue QUIDEL CORPORATION
13 20816101025651 MOL3560 MOL3560 Simplexa™ GBS Positive Control Pack DIASORIN MOLECULAR LLC
14 20816101025644 MOL3550 MOL3550 Simplexa™ GBS Direct DIASORIN MOLECULAR LLC
15 15420045510906 GBS CTRLS KIT, PANTHER FUSION, IVD PRD-04485 Panther Fusion HOLOGIC, INC.
16 15420045510890 GBS KIT, 96T, IVD PRD-04484 Panther Fusion HOLOGIC, INC.
17 15420045510470 INTERNAL CONTROL-X, 960T, IVD PRD-04476 Panther Fusion HOLOGIC, INC.
18 15420045510463 EXTRACTION REAGENT-X, 960T, IVD PRD-04477 Panther Fusion HOLOGIC, INC.
19 10814278020045 200400 200400 NeuMoDx GBS Test Strip NeuMoDxTM GBS Test Strip NEUMODX MOLECULAR, INC.
20 07332940007690 GX-IV R2 GX-IV R2 XPERT, GENEXPERT DX SYSTEM GeneXpert® CEPHEID
21 07332940007683 GX-II R2 GX-II R2 XPERT, GENEXPERT DX SYSTEM GeneXpert® CEPHEID
22 07332940007669 GXGBSLBXC GXGBSLBXC-120 GBS LB XC Xpert® CEPHEID
23 07332940007652 GXGBSLBXC GXGBSLBXC-10 GBS LB XC Xpert® CEPHEID
24 07332940006822 INFINITY48-16 900-0453 Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 GeneXpert® CEPHEID
25 07332940006730 GXXVI-12 900-0391 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
26 07332940006723 GXIV-3 900-0144 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
27 07332940006716 GXIV-1 900-0141 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
28 07332940006709 GXIV-3 900-0139 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
29 07332940004910 SC2500N17-1 SC2500N17-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
30 07332940004903 SC2500N18-1 SC2500N18-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
31 07332940004880 SC2500N19-1 SC2500N19-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
32 07332940004866 SC2500N2-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
33 07332940004842 SC2500N3-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
34 07332940004835 SC2500N3-1R SC2500N3-1R SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
35 07332940004804 SC2500N4-1 SC2500N4-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
36 07332940004798 SC2500N4-1R SC2500N4-1R SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
37 07332940004767 SC2500N5-1 SC2500N5-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
38 07332940004743 SC2500N6-1 SC2500N6-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
39 07332940004606 SC2500N1-1 SC2500N1-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
40 07332940004583 SC2500N12-1 SC2500N12-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
41 07332940004569 SC2500N13-1 SC2500N13-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
42 07332940004545 SC2500N14-1 SC2500N14-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
43 07332940004538 SC2500N15-1 SC2500N15-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
44 07332940004521 SC2500N16-1 SC2500N16-1 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B SmartCycler Dx System CEPHEID
45 07332940004361 GX-I 900-0523 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
46 07332940004309 GXII-2 900-0542 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
47 07332940004163 GXXVI-16 900-0426 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
48 07332940004156 GXXVI-12 900-0427 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
49 07332940004149 GXXVI-8, GXXVI-12 900-0428 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
50 07332940004132 GXXVI-4, GXXVI-4-8 900-0429 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID