No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 15099590704087 | B1017-435 | Neg Urine Combo 85 | LQM,LTW,LRG,JWY,LTT | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Inst Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems,Panels, Test, Susceptibility, Antimicrobial | MicroScan | ||
2 | 15099590704070 | B1017-434 | Neg Urine Combo 84 | LQM,LTW,LRG,JWY,LTT | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Inst Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems,Panels, Test, Susceptibility, Antimicrobial | MicroScan | ||
3 | 15099590765385 | C89645 | Neg Urine Combo 103 | JWY,LRG,LTT,LTW,LQM | Manual Antimicrobial Susceptibility Test Systems,Instrument For Auto Reader & In Manual Antimicrobial Susceptibility Test Systems,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Panels, Test, Susceptibility, Antimicrobial,Susceptibility Test Cards, Antimicrobial,Gram Negative Identification Panel | 1 | MicroScan | |
4 | 15099590733919 | C48640 | Neg Urine Combo 90 | LQM,LTW,LTT,LRG,JWY | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Pane Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Panels, Test, Susceptibility, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems | MicroScan | ||
5 | 15099590707118 | DxA 5000 | DxA 5000 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | DxA 5000 | |
6 | 15099590540210 | 6607098 | 6607098 | IMMUNO-TROL Low Cells | JPK | Mixture, Hematology Quality Control | 2 | IMMUNO-TROL Low Cells |
7 | 15099590250683 | 7546914 | 7546914 | COULTER LATRON Control | GKL | Counter, Cell, Automated (Particle Counter) | 2 | COULTER Latron |
8 | 15099590060206 | OSR6637 | Bicarbonate | KHS | Enzymatic, Carbon-Dioxide | 2 | AU | |
9 | 15099590222925 | 465980 | 465980 | Vigil Lipid Control Level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Vigil |
10 | 15099590742751 | C69058 | C69058 | The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SA The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only.The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization. | QKO | Reagent, Coronavirus Serological | Access SARS-CoV-2 IgG II Calibrator | |
11 | 15099590701574 | C11478 | UniCel DxH 900 Coulter Cellular Analysis System | GKZ | Counter, Differential Cell | 2 | DxH 900 Hematology System | |
12 | 15099590672539 | B36633 | B36633 | CYTO-STAT /COULTER CLONE MsIgG2a-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE MsIgG2a-RD1 |
13 | 15099590672522 | B36631 | B36631 | CYTO-STAT /COULTER CLONE Mo2-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE Mo2-FITC |
14 | 15099590672461 | B36623 | B36623 | CYTO-STAT /COULTER CLONE MsIgG2b-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE MsIgG2b-FITC |
15 | 15099590672454 | B36536 | B36536 | CYTO-STAT /COULTER CLONE B4-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE B4-RD1 |
16 | 15099590663827 | 8448044 | 8448044 | COULTER Isoton III Diluent 20L | GIF | Diluent, Blood Cell | 1 | COULTER Isoton III Diluent |
17 | 15099590663803 | 8448177 | 8448177 | COULTER Lyse S III diff Lytic Reagent (5L) | GGK | Products, Red-Cell Lysing Products | 1 | COULTER Lyse S III diff Lytic Reagent |
18 | 15099590663797 | 8448155 | 8448155 | COULTER Lyse S III diff Lytic Reagent (1L) | GGK | Products, Red-Cell Lysing Products | 1 | COULTER Lyse S III diff Lytic Reagent |
19 | 15099590638191 | 378600 | 378600 | COULTER PrepPlus 2 | PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cyto Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 1 | PrepPlus 2 |
20 | 15099590625856 | 8546733 | 8546733 | COULTER Isoton III Diluent (20L) | GIF | Diluent, Blood Cell | 1 | COULTER Isoton III Diluent |
21 | 15099590625771 | 8547148 | 8547148 | COULTER Isoton 4 Diluent (20L) | GIF | Diluent, Blood Cell | 1 | COULTER Isoton 4 Diluent |
22 | 15099590624903 | A31590 | A31590 | The Access Toxo IgG QC is intended for monitoring system performance of the Acce The Access Toxo IgG QC is intended for monitoring system performance of the Access Toxo IgG assay. | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Access Toxo IgG QC |
23 | 15099590624811 | 33209 | 33209 | The Access CEA QC (BSA matrix) controls are intended for monitoring the system p The Access CEA QC (BSA matrix) controls are intended for monitoring the system performance of immunoenzymatic procedures for the quantitative measurement of Carcinoembryonic Antigen (CEA) using Access CEA reagents. | DHX | System, Test, Carcinoembryonic Antigen | 2 | Access CEA QC |
24 | 15099590583996 | Power Link | B05033 | Power Link | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Power Link |
25 | 15099590572839 | UPS (CXP) | 626553 | Cytomics FC 500 with CXP Software | GKZ | Counter, Differential Cell | 2 | Cytomics FC500 |
26 | 15099590572822 | UPS (MPL) | 626554 | Cytomics FC 500 MPL with MXP Software | GKZ | Counter, Differential Cell | 2 | Cytomics FC500 |
27 | 15099590542863 | 6602940 | 6602940 | COULTER CLONE MsIgM-FITC | GKZ | Counter, Differential Cell | 2 | CC MsIgM-RD1 |
28 | 15099590542535 | 6602872 | 6602872 | COULTER CLONE MsIgG1 | GKZ | Counter, Differential Cell | 2 | CC MsIgG1 Isotypic Control |
29 | 15099590542511 | 6602884 | 6602884 | COULTER CLONE MsIgG1-RD1 | GKZ | Counter, Differential Cell | 2 | CC MsIgG1-RD1 |
30 | 15099590542399 | 6603838 | 6603838 | COULTER CLONE KC56 (T-200)-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE KC56 (T-200)-FITC |
31 | 15099590542313 | 8547008 | 8547008 | IsoFlow Sheath Fluid | GIF | Diluent, Blood Cell | 1 | ISOFLOW SHEATH FLUID |
32 | 15099590541590 | 6602507 | 6602507 | COULTER CLONE Mo2-FITC | GKZ | Counter, Differential Cell | 2 | CC Mo2-FITC (CD14-FITC) |
33 | 15099590541378 | 6603822 | 6603822 | CYTO-STAT/COULTER CLONE 3A1-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT/COULTER CLONE 3A1-RD1 |
34 | 15099590541354 | 6603825 | 6603825 | COULTER CLONE 3A1-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE 3A1-FITC |
35 | 15099590540951 | 6602381 | 6602381 | COULTER CLONE B1-FITC | GKZ | Counter, Differential Cell | 2 | CC B1-FITC (CD20-FITC) |
36 | 15099590540890 | 627808 | 627808 | FlowCARE PLG CD4 Reagent (CD45-FITC/CD4-PE) | GKZ | Counter, Differential Cell | 2 | FlowCARE PLG CD4 Reagent |
37 | 15099590540883 | 6603909 | 6603909 | CYTO-STAT/COULTER CLONE Mo2-RD1/KC56(T-200)-FITC | GKZ | Counter, Differential Cell | 2 | CS/CC Mo2-RD1/KC56(T-200)-FITC |
38 | 15099590540449 | 6607077 | 6607077 | IMMUNO-TROL Cells | JPK | Mixture, Hematology Quality Control | 2 | IMMUNO-TROL Cells |
39 | 15099590539757 | 6604500 | 6604500 | CYTO-STAT/COULTER CLONE Mo2-RD1 | GKZ | Counter, Differential Cell | 2 | CS/CC Mo2-RD1 (CD14-RD1) |
40 | 15099590539719 | 6604621 | 6604621 | CYTO-STAT/COULTER CLONE CD3(IgG1)-RD1 | GKZ | Counter, Differential Cell | 2 | CS/CC CD3(IgG1)-RD1 |
41 | 15099590539207 | 6602705 | 6602705 | COULTER CLONE NKH-1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE NKH-1 |
42 | 15099590250973 | 8547196 | 8547196 | COULTER LH Series Retic Pak Reagent Kit | GGK | Products, Red-Cell Lysing Products | 1 | COULTER LH Series Retic Pak Reagent Kit |
43 | 15099590234089 | 721542 | 721542 | LH Series Cleaner (5L) | JCB | Detergent | 1 | LH Series Cleaner |
44 | 15099590250935 | 8546859 | 8546859 | IsoFlow Sheath Fluid | GIF | Diluent, Blood Cell | 1 | ISOFLOW SHEATH FLUID |
45 | 15099590250751 | 7547201 | 7547201 | COULTER TruColor Giemsa Stain | KQC | Stains, Hematology | 1 | COULTER TruColor Giemsa Stain |
46 | 15099590250720 | 7547180 | 7547180 | COULTER TruColor Wright Stain Buffer | KQC | Stains, Hematology | 1 | COULTER TruColor Wright Stain Buffer |
47 | 15099590250690 | 7546915 | 7546915 | COULTER LATRON Primer | GKL | Counter, Cell, Automated (Particle Counter) | 2 | COULTER Latron |
48 | 15099590233785 | 628028 | 628028 | COULTER Retic-X Cell Control | JPK | Mixture, Hematology Quality Control | 2 | COULTER Retic-X |
49 | 15099590233686 | 628017 | 628017 | COULTER DxH Diluent | GIF | Diluent, Blood Cell | 1 | COULTER DxH Diluent |
50 | 15099590232931 | 177017 | 177017 | QuickComp 4 Kit | GKZ | Counter, Differential Cell | 2 | QuickCOMP 4 Kit |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 15099590705169 | Flow Cytometry Software | C21166 | Kaluza C Flow Cytometry Software | Kaluza C | BECKMAN COULTER, INC. |
2 | 15099590705152 | 5 User Network Educational License | C10581 | Kaluza C 5 User Network Educational License | Kaluza C | BECKMAN COULTER, INC. |
3 | 15099590705145 | 10 User Network Educational License | C10580 | Kaluza C 10 User Network Educational License | Kaluza C | BECKMAN COULTER, INC. |
4 | 15099590705138 | Single User 1 Year Educational License | C10579 | Kaluza C Single User 1 Year Educational License | Kaluza C | BECKMAN COULTER, INC. |
5 | 15099590705121 | Perpetual Education License | C10578 | Kaluza C Perpetual Education License | Kaluza C | BECKMAN COULTER, INC. |
6 | 15099590705114 | 5 User Network | C10576 | Kaluza C 5 User Network | Kaluza C | BECKMAN COULTER, INC. |
7 | 15099590705107 | 10 User Network | C10577 | Kaluza C 10 User Network | Kaluza C | BECKMAN COULTER, INC. |
8 | 15099590705091 | Single Use 1 Year License | C10575 | Kaluza C Single Use 1 Year License | Kaluza C | BECKMAN COULTER, INC. |
9 | 15099590705084 | Perpetual License | C10574 | Kaluza C Perpetual License | Kaluza C | BECKMAN COULTER, INC. |
10 | 15099590589813 | AutoMate 800 Sample Processor | A20743 | AutoMate 800 Sample Processor | AutoMate 800 Sample Processor | BECKMAN COULTER, INC. |
11 | 15099590589806 | AutoMate 600 Sample Processor | A20745 | AutoMate 600 Sample Processor | AutoMate 600 Sample Processor | BECKMAN COULTER, INC. |
12 | 15099590364465 | AutoMate 1200 | ODL25120 | AutoMate1200 – Standard Sorter | Automate 2500 Family | BECKMAN COULTER, INC. |
13 | 15099590364106 | AutoMate 1250 | ODL25125 | AutoMate1250 – Sorter with Aliquot Module | Automate 2500 Family | BECKMAN COULTER, INC. |
14 | 15099590364090 | AutoMate 2500 | ODL25250 | AutoMate2500 – High Speed Sorter | Automate 2500 Family | BECKMAN COULTER, INC. |
15 | 15099590364083 | AutoMate 2550 | ODL25255 | AutoMate2550 – High Speed Sorter with Aliquot Module | Automate 2500 Family | BECKMAN COULTER, INC. |
16 | 09120052071351 | 30220141 00 | 30220141 | This media contains V 7.4 of the following registered Medical Devices:(DI)091200 This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X) | USB-STICK MAGELLAN PRO V7.4 | TECAN AUSTRIA GMBH |
17 | 09120052071238 | 30204301 00 | 30204301 | This media contains V 7.3 of the following registered Medical Devices:(DI)091200 This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X) | USB-STICK MAGELLAN PRO V 7.5 | TECAN AUSTRIA GMBH |
18 | 09120052071092 | 30185384 00 | 30185384 | This media contains V 7.4 of the following registered Medical Devices:(DI)091200 This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X) | USB-STICK MAGELLAN PRO V7.4 | TECAN AUSTRIA GMBH |
19 | 09120052071023 | 30182624 00 | 30182624 | This media contains the following registered Medical Devices:(DI) 09120052070996 This media contains the following registered Medical Devices:(DI) 09120052070996 MAGELLAN V7.X(DI) 09120052071009 MAGELLAN TRACKER V7.X | USB-STICK MAGELLAN 7.3 SP2 | TECAN AUSTRIA GMBH |
20 | 09120052071009 | MAGELLAN TRACKER V7.X | 30183890 | Reader control and data reduction software for Tecan Microplate Reader. | MAGELLAN | TECAN AUSTRIA GMBH |
21 | 09120052070996 | MAGELLAN V7.X | 30183889 | Reader control and data reduction software for Tecan Microplate Reader. | MAGELLAN | TECAN AUSTRIA GMBH |
22 | 09120052070941 | 30141795 00 | 30141795 | This media contains V 7.3 of the following registered Medical Devices:(DI)091200 This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X) | USB-STICK MAGELLAN PRO V 7.3 | TECAN AUSTRIA GMBH |
23 | 09120052070910 | MAGELLAN PRO TRACKER V 7.X | Reader control and data reduction software for Tecan Microplate Reader. | MAGELLAN PRO | TECAN AUSTRIA GMBH | |
24 | 09120052070880 | MAGELLAN PRO V 7.X | Reader control and data reduction software for Tecan Microplate Reader. | MAGELLAN PRO | TECAN AUSTRIA GMBH | |
25 | 07640172343012 | PTB | ProTube is designed to automate biological sample collection process. ProTube en ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters. | ProTube | INPECO SA | |
26 | 07640172343005 | PTB | The ProTube System is designed to automate biological sample collection process. The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out. | ProTube | INPECO SA | |
27 | 07613336177129 | 09180443001 | 09180443001 | cobas® infinity central lab | ROCHE DIAGNOSTICS GMBH | |
28 | 07613336164846 | 08763640001 | 08763640001 | cobas pro B-Gate update Kit | ROCHE DIAGNOSTICS GMBH | |
29 | 07613336164280 | 08739170001 | 08739170001 | cobas infinity POC IT solutions | ROCHE DIAGNOSTICS GMBH | |
30 | 07613336157046 | 08420254001 | 08420254001 | cobas infinity POC remote access | ROCHE DIAGNOSTICS GMBH | |
31 | 07613336156520 | 08368449001 | 08368449001 | BCM for cobas 8100 | ROCHE DIAGNOSTICS GMBH | |
32 | 07613327568998 | 0794111090 | 0794-111-090 | QBL Software License | N/A | STRYKER CORPORATION |
33 | 07613327568981 | 0694-002-100 | 0694-002-100 | + EMR/QBL APPLICATION | SURGICOUNT | STRYKER CORPORATION |
34 | 07311091391681 | 139168 | 139168 | HemoCue® 801 Connect | HemoCue® 801 Connect | HEMOCUE AB |
35 | 06438147352401 | 5002-0540 | 5002-0540 | The MSMS Workstation is intended for use as a calculator/data processing softwar The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data. | MSMS Workstation | WALLAC OY |
36 | 06438147320905 | 5002-0500 | 5002-0500 | Specimen Gate® Screening Center™ is intended to be used for data management of n Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. | Screening Center | WALLAC OY |
37 | 06438147153312 | 5002-0180 | 5002-0180 | Specimen Gate® Laboratory is a modular laboratory information management system Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories. | Specimen Gate Laboratory | WALLAC OY |
38 | 06438147153275 | 5002-0130 | 5002-0130 | Specimen Gate® PatientCare™ is intended for management of the follow-up workflow Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system. | PatientCare | WALLAC OY |
39 | 05700574037314 | K5810AA | Bench LAB CNV | Bench Lab CNV | AGILENT TECHNOLOGIES BELGIUM | |
40 | 05700574035631 | K5849AA | Alissa Interpret | Alissa Interpret | AGILENT TECHNOLOGIES BELGIUM | |
41 | 05415062388310 | CI4054279 | Software to identify heart failure patients who may be at risk of having wtATTR-CM | wtATTR-CM AcceleraTTR™ | PFIZER INC. | |
42 | 04048534002011 | 0760-0101 | 0760-0101 | EKF Link is a data and device management system that enables healthcare professi EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes.EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link.EKF Link facilitates the setting of configurable options of connected analyzers. | EKF Link | EKF-DIAGNOSTIC GMBH |
43 | 04015630942305 | 06884750001 | 06884750001 | B-Gate Interface | ROCHE DIAGNOSTICS GMBH | |
44 | 04015630936007 | 07154003001 | 07154003001 | cobas® infinity central lab | ROCHE DIAGNOSTICS GMBH | |
45 | 04015630929078 | 05349966001 | 05349966001 | cobas p 701 Post-Analytical Unit | ROCHE DIAGNOSTICS GMBH | |
46 | 04015630929061 | 05158494001 | 05158494001 | cobas p 501 post-analytical unit | ROCHE DIAGNOSTICS GMBH | |
47 | 04015630035342 | 04420306001 | 04420306001 | cobas IT 1000 | ROCHE DIAGNOSTICS GMBH | |
48 | 03770027519041 | TD-Web | TD-Web is a web solution to easily manage orders creation, optimize collection TD-Web is a web solution to easily manage orders creation, optimize collection management and provide real-time results access at the patient’s bedside. | TD-Web | TECHNIDATA | |
49 | 03770027519034 | TDWorkstation | TDWorkstation is a powerful software designed to interface instruments with any TDWorkstation is a powerful software designed to interface instruments with any Laboratory Information System (LIS) and manage results with efficiency and flexibility. | TDWorkstation | TECHNIDATA | |
50 | 03770027519010 | TDHisto/Cyto | TDHisto/Cyto is a software used for managing medical information in the field TDHisto/Cyto is a software used for managing medical information in the field of laboratories performing histology, non-gynecological and gynecological cytology and autopsy activities.. | TDHisto/Cyto | TECHNIDATA |