| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00380740200053 | 08P433C | 08P433C | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 2 | 00380740200060 | 09P271B | 09P271B | Alinity i Anti-CCP Assay File | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Alinity |
| 3 | 00380740200046 | 08P435C | 08P435C | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 4 | 00380740200039 | 08P431C | 08P431C | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 5 | 00380740200022 | 08P437C | 08P437C | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 6 | 00380740199487 | 04V511B | 04V511B | Alinity c Total Bilirubin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 7 | 00380740195458 | 07P701C | 07P701C | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 8 | 00380740195380 | 08P181B | 08P181B | Alinity c A-ALT Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 9 | 00380740194208 | 09P523B | 09P523B | Alinity c BenzSQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 10 | 00380740194192 | 09P521B | 09P521B | Alinity c BenzQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 11 | 00380740194093 | 06S611A | 06S611A | Alinity i COV 2IgGII Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 12 | 00380740193638 | 04Z211A | 04Z211A | Alinity i STAT High Sensitivity Tropopnin-I | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 13 | 00380740193577 | 07P701B | 07P701B | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 14 | 00380740192723 | 04U093A | 04U093A | Alinity c Uric2-U Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 15 | 00380740192464 | 06R911A | 06R911A | Alinity i COV-2 IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 16 | 00380740189105 | 08P013B | 08P013B | Alinity c CrEnzU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 17 | 00380740189099 | 08P011B | 08P011B | Alinity c CrEnz Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 18 | 00380740186418 | 04T843A | 04T843A | Alinity c ALT2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 19 | 00380740186401 | 04T841A | 04T841A | Alinity c ALT2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 20 | 00380740186395 | 04T863A | 04T863A | Alinity c AST2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 21 | 00380740186388 | 04T861A | 04T861A | Alinity c AST2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 22 | 00380740186364 | 04U091A | 04U091A | Alinity c Uric2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 23 | 00380740186265 | 04T961A | 04T961A | Alinity c GGT2 Asasy File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 24 | 00380740186159 | 04T811A | 04T811A | Alinity c TPRO2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 25 | 00380740185978 | 07P569A | 07P569A | Alinity c CardiacCRP Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 26 | 00380740181000 | 09P533A | 09P533A | Alinity c SerBENZQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 27 | 00380740180201 | 08P433B | 08P433B | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 28 | 00380740180195 | 08P435B | 08P435B | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 29 | 00380740180188 | 08P431B | 08P431B | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 30 | 00380740180171 | 08P437B | 08P437B | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 31 | 00380740180164 | 08P541B | 08P541B | Alinity c Phenytoin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 32 | 00380740180157 | 08P591B | 08P591B | Alinity c Salicylate Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 33 | 00380740180140 | 08P193C | 08P193C | Alinity c MagnesiumU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 34 | 00380740180133 | 08P191C | 08P191C | Alinity c Magnesium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 35 | 00380740180126 | 09P631B | 09P631B | Alinity c IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 36 | 00380740180119 | 08P531D | 08P531D | Alinity c Lithium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 37 | 00380740180089 | 08P041B | 08P041B | Alinity c Microalb Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 38 | 00380740180058 | 08P551B | 08P551B | Alinity c Gentamicin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 39 | 00380740180041 | 09P931B | 09P931B | Alinity c Cerulo Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 40 | 00380740180034 | 07P591B | 07P591B | Alinity c U/CSF Prot Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 41 | 00380740180027 | 07P751B | 07P751B | Alinity c Ultra HDL Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 42 | 00380740180010 | 07P771B | 07P771B | Alinity c Trig Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 43 | 00380740180003 | 09P861B | 09P861B | Alinity c Prealbumin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 44 | 00380740179991 | 07P761B | 07P761B | Alinity c Chol Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 45 | 00380740179984 | 08P021B | 08P021B | Alinity c AlbuminBCG Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 46 | 00380740179977 | 07P691C | 07P691C | Alinity i Free T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 47 | 00380740179960 | 07P941C | 07P941C | Alinity i Total T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 48 | 00380740179571 | 07P567A | 07P567A | Alinity c CRP WR Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 49 | 00380740179564 | 07P565A | 07P565A | Alinity c CRP HS Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 50 | 00380740179199 | 08P2121 | 08P2121 | Alinity c Lactic Acid Reagent Kit 1000 Tests | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Alinity |
| 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. |