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 | 04580262049826 | 60-01-9003 | 60-01-9003 | MyeLyte Touch is discrete photometric clinical chemistry analyzer. The device is MyeLyte Touch is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. MyeLyte Touch with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, MyeLyte Touch with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. | MyeLyte Touch | TOKYO BOEKI MEDISYS INC. |
2 | 04580262049819 | 60-01-9002 | 60-01-9002 | DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. DZ-Lite c270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, DZ-Lite c270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. | DZ-Lite c270 | TOKYO BOEKI MEDISYS INC. |
3 | 04580262049802 | 60-01-9001 | 60-01-9001 | IMMTOX 270 is discrete photometric clinical chemistry analyzer. The device is in IMMTOX 270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. IMMTOX 270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, IMMTOX 270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. | IMMTOX 270 | TOKYO BOEKI MEDISYS INC. |
4 | 04580262046825 | 50-24-0748 | 50-24-0748 | Acid Washing Solution | TOKYO BOEKI MEDISYS INC. | |
5 | 04580262046818 | 50-24-0747 | 50-24-0747 | Alkaline Washing Solution | TOKYO BOEKI MEDISYS INC. | |
6 | 04580262046528 | 50-27-0782F | 50-27-0782F | ISE Cleaner (5%) | TOKYO BOEKI MEDISYS INC. | |
7 | 04580262046511 | 50-27-0781F | 50-27-0781F | ISE Cleaner (1%) | TOKYO BOEKI MEDISYS INC. | |
8 | 04580262040014 | 50-01-0000 | 50-01-0000 | BIOLIS 50i Superior is discrete photometric clinical chemistry analyzer. The dev BIOLIS 50i Superior is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. BIOLIS 50i Superior with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 50i Superior with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. | BIOLIS 50i | TOKYO BOEKI MEDISYS INC. |
9 | 04580262028227 | 30-27-0905F | 30-27-0905F | Calibrator 2 (140mL) | TOKYO BOEKI MEDISYS INC. | |
10 | 04580262020016 | 23-01-0000 | 23-01-0000 | Biolis 24i Premium is discrete photometric clinical chemistry analyzer. The devi Biolis 24i Premium is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. Biolis 24i Premium with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, Biolis 24i Premium with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. | Biolis 24i Premium | TOKYO BOEKI MEDISYS INC. |
11 | 04580262016019 | 60-22-0263 | 60-22-0263 | Calibrator Set A,B | TOKYO BOEKI MEDISYS INC. | |
12 | 04580262016002 | 60-01-0001 | 60-01-0001 | BIOLIS 30i is discrete photometric clinical chemistry analyzer. The device is in BIOLIS 30i is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. BIOLIS 30i with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 30i with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. | BIOLIS 30i | TOKYO BOEKI MEDISYS INC. |
13 | 04580262010352 | 20-27-0483F | 20-27-0483F | Dialysis Calibrator | TOKYO BOEKI MEDISYS INC. | |
14 | 04580262010345 | 20-27-0482 | 20-27-0482 | Diluent for Urine | TOKYO BOEKI MEDISYS INC. | |
15 | 04580262010338 | 20-27-0480 | 20-27-0480 | Urine Calibrator Set | TOKYO BOEKI MEDISYS INC. | |
16 | 04580262010307 | 20-27-0477F | 20-27-0477F | Calibrator 1 | TOKYO BOEKI MEDISYS INC. | |
17 | 04580262010291 | 20-27-0473F | 20-27-0473F | Reference Electrode | TOKYO BOEKI MEDISYS INC. | |
18 | 04580262010284 | 20-27-0476F | 20-27-0476F | Cl Electrode | TOKYO BOEKI MEDISYS INC. | |
19 | 04580262010277 | 20-27-0475F | 20-27-0475F | K Electrode | TOKYO BOEKI MEDISYS INC. | |
20 | 04580262010260 | 20-27-0474F | 20-27-0474F | Na Electrode | TOKYO BOEKI MEDISYS INC. | |
21 | 04580262010222 | SP2209 | SP2209 | Acid Washing Solution | TOKYO BOEKI MEDISYS INC. | |
22 | 04580262010208 | SP2208 | SP2208 | Alkaline Washing Solution | TOKYO BOEKI MEDISYS INC. | |
23 | 04049016109723 | YG 0153-0101 | EUROBlotOne | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
24 | 04049016109716 | YG 0033-0101-6 | Sprinter XL (model 160 samples, IFA/ELISA) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
25 | 04049016109686 | YG 0033-0101-3 | Sprinter XL (model 160 samples, IFA/ELISA incl. Incubator) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
26 | 04049016109679 | YG 0033-0101-26 | Sprinter XL (model 240 samples, IFA/ELISA) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
27 | 04049016109648 | YG 0033-0101-23 | Sprinter XL (model 240 samples, IFA/ELISA incl. Incubator) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
28 | 04049016100607 | YG 0032-0101-3 | IF Sprinter (model IFA/ELISA with ReSa-Trax) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
29 | 04049016100591 | YG 0032-0101-2 | IF Sprinter (model IFA/ELISA) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
30 | 04049016090397 | YG 0015-0101 | EUROIMMUN Analyzer I-2P | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
31 | 04049016068792 | YG 0014-0101 | EUROIMMUN Analyzer I | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
32 | 04015630946402 | 7790198001 | 7790198001 | cobas 6000 c501 module | ROCHE DIAGNOSTICS GMBH | |
33 | 04015630946341 | 05964075001 | 05964075001 | cobas 8000 cobas ISE module | ROCHE DIAGNOSTICS GMBH | |
34 | 04015630946327 | 07649142001 | 07649142001 | cobas c 513 clinical chemistry analyzer | ROCHE DIAGNOSTICS GMBH | |
35 | 04015630946198 | 07682913001 | 07682913001 | cobas e 801 Immunoassay Analyzer | ROCHE DIAGNOSTICS GMBH | |
36 | 04015630938568 | 07354452001 | 07354452001 | cobas e 601 for the cobas 6000 e 601 UL configuration | ROCHE DIAGNOSTICS GMBH | |
37 | 04015630938551 | 07354436001 | 07354436001 | cobas 6000 Core Unit | ROCHE DIAGNOSTICS GMBH | |
38 | 04015630937103 | 04775279001 | 04775279001 | cobas e 411 Immunoassay Analyzer | ROCHE DIAGNOSTICS GMBH | |
39 | 04015630930845 | 6473245001 | 6473245001 | cobas 8000 c 702 Module | ROCHE DIAGNOSTICS GMBH | |
40 | 04015630929764 | 05990378001 | 05990378001 | cobas e 602 Immunoassay Analyzer | ROCHE DIAGNOSTICS GMBH | |
41 | 04015630928354 | 5964067001 | 05964067001 | cobas 8000 c 502 Module | ROCHE DIAGNOSTICS GMBH | |
42 | 04015630928330 | 05641446001 | 05641446001 | cobas 8000 Core Unit | ROCHE DIAGNOSTICS GMBH | |
43 | 04015630928255 | 5641489001 | 5641489001 | cobas 8000 c 701 Module | ROCHE DIAGNOSTICS GMBH | |
44 | 04015630927036 | 4528778001 | 4528778001 | cobas c 111 analyzer | ROCHE DIAGNOSTICS GMBH | |
45 | 04015630924769 | 04777433001 | 04777433001 | cobas c 111 analyzer with ISE | ROCHE DIAGNOSTICS GMBH | |
46 | 04015630924721 | 04775201001 | 04775201001 | cobas e 411 Immunoassay Analyzer | ROCHE DIAGNOSTICS GMBH | |
47 | 04015630924714 | 04745922001 | 04745922001 | cobas e 601 Immunoassay Analyzer | ROCHE DIAGNOSTICS GMBH | |
48 | 03760173851010 | IS-CC100 | IDS-iSYS Cuvettes | IMMUNODIAGNOSTIC SYSTEMS FRANCE | ||
49 | 03661540600357 | 6003-760 | Viva-ProE® | ELITECHGROUP B.V. | ||
50 | 03661540600210 | 6002-940 | Viva-Jr® | ELITECHGROUP B.V. |