| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00817273020471 | MAGO 4S | Mago 4S Anayzer | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | Diamedix | |
| 2 | 00817273020464 | MAGO Plus | MAGO Plus chemistry analyzer | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | Diamedix | |
| 3 | 00817273020457 | 789-009 | "789-009 EZ Complement High Control" | DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | Diamedix | |
| 4 | 00817273020440 | 789-008 | "789-008 EZ Complement Low Control" | DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | Diamedix | |
| 5 | 00817273020433 | 789-006 | "789-006 EZ Complement Reference Serum" | DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | Diamedix | |
| 6 | 00817273020426 | 789-001 | "789-001 EZ Complement Cells" | DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | Diamedix | |
| 7 | 00817273020419 | 720-850 | "720-850 Mycoplasma IgG Test Kit" | LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 1 | Diamedix | |
| 8 | 00817273020402 | 720-830 | "720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit" | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | Diamedix | |
| 9 | 00817273020396 | 720-790 | "720-790 ANA ELISA Screen Test Kit" | LKJ | Antinuclear Antibody, Antigen, Control | 2 | Diamedix | |
| 10 | 00817273020389 | 720-710 | "720-710 Rheumatoid Factor Test Kit" | DHR | System, Test, Rheumatoid Factor | 2 | Diamedix | |
| 11 | 00817273020372 | 720-700 | "720-700 anti-dsDNA Test Kit" | LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | Diamedix | |
| 12 | 00817273020365 | 720-650 | "720-650 EBV-EA-D IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
| 13 | 00817273020358 | 720-640 | "720-640 EBV-EA-D IgG Test Kit" | GNP | Antiserum, Cf, Epstein-Barr Virus | 1 | Diamedix | |
| 14 | 00817273020341 | 720-630 | "720-630 EBNA-1 IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
| 15 | 00817273020334 | 720-620 | "720-620 EBNA-1 IgG Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
| 16 | 00817273020327 | 720-610 | "720-610 EBV-VCA IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
| 17 | 00817273020310 | 720-600 | "720-600 EBV-VCA IgG Test Kit" | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | Diamedix | |
| 18 | 00817273020303 | 720-540 | "720-540 Mumps IgG Test Kit" | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | Diamedix | |
| 19 | 00817273020297 | 720-520 | "720-520 Measles IgG Test Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
| 20 | 00817273020280 | 720-480 | "720-480 anti-Cardiolipin Screen" | JZO | System, Test, Thyroid Autoantibody | 2 | Diamedix | |
| 21 | 00817273020273 | 720-460 | "720-460 anti-TG IgG Test Kit" | JZO | System, Test, Thyroid Autoantibody | 2 | Diamedix | |
| 22 | 00817273020266 | 720-450 | "720-450 anti-TPO IgG Test Kit" | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | Diamedix | |
| 23 | 00817273020242 | 720-430 | "720-430 anti-MPO (P-ANCA) IgG Test Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
| 24 | 00817273020235 | 720-420 | "720-420 anti-Cardiolipin IgATest Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
| 25 | 00817273020228 | 720-400 | "720-400 anti-Cardiolipin IgG/IgM Test Kit" | LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 2 | Diamedix | |
| 26 | 00817273020211 | 720-380 | "720-380 VZV IgG Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
| 27 | 00817273020204 | 720-370 | "720-370 Rubella IgM Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
| 28 | 00817273020198 | 720-360 | "720-360 Rubella IgG Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
| 29 | 00817273020181 | 720-350 | "720-350 HSV 1&2 IgM Test Kit" | LCG | Intestinal Splinting Tubes | 2 | Diamedix | |
| 30 | 00817273020174 | 720-340 | "720-340 HSV 1&2 IgG Test Kit" | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Diamedix | |
| 31 | 00817273020167 | 720-330 | "720-330 CMV IgM Test Kit" | LJO | Antigen, Iha, Cytomegalovirus | 2 | Diamedix | |
| 32 | 00817273020150 | 720-320 | "720-320 CMV IgG Test Kit" | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Diamedix | |
| 33 | 00817273020143 | 720-310 | "720-310 Toxoplasma IgM Test Kit" | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Diamedix | |
| 34 | 00817273020136 | 720-300 | "720-300 Toxoplasma IgG Test Kit" | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Diamedix | |
| 35 | 00817273020129 | 720-290 | "720-290 anti-Jo-1 Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 36 | 00817273020112 | 720-280 | "720-280 anti-Scl-70 Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 37 | 00817273020105 | 720-270 | "720-270 anti-SM/RNP Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 38 | 00817273020099 | 72-260 | 720-260 anti-SSB Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 39 | 00817273020082 | 720-250 | 720-250 anti-SSA Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 40 | 00817273020075 | 720-240 | 720-240 anti-SM Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 41 | 00817273020068 | 720-230 | 720-230 ENA-6 Screen Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 42 | 00817273020051 | 720-130 | 720-130 H.pylori IgG Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 43 | 00817273020044 | 300-371A | "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
| 44 | 00817273020037 | 300-331A | 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit | LYR | Helicobacter Pylori | 1 | Diamedix | |
| 45 | 00817273020020 | 300-312A | "300-312A Toxoplasma IgM Capture Lyoph. Ag. Accessory Kit" | LJO | Antigen, Iha, Cytomegalovirus | 2 | Diamedix | |
| 46 | 00817273020013 | 251-035 | 251-035 ProbeClean Concentration Kit" | LJO | Antigen, Iha, Cytomegalovirus | 2 | Diamedix | |
| 47 | 00817273020006 | 250-030 | Calibration Test Kit | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Diamedix |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04250289510387 | 54.051.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | AESKUSLIDES ANCA Formalin | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 2 | 04250289510370 | 54.050.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | AESKUSLIDES ANCA Ethanol | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 3 | 04250289510363 | 54.101.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | AESKUSLIDES ANCA Formalin | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 4 | 04250289510356 | 54.100.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | AESKUSLIDES ANCA Ethanol | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 5 | 04250289503556 | 30-7303US | 30-7303US | AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified nati AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis. 30'+30'+30' automation incubation. | AESKULISA® MPO | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 6 | 04250289503549 | 30-7302US | 30-7302US | AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly pur AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis.30'+30'+30' automation incubation. | AESKULISA® PR3 sensitive | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 7 | 04250289501361 | 3303 | AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified nati AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis. | AESKULISA® MPO | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 8 | 04250289501354 | 3302 | AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly pur AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis | AESKULISA® PR3 sensitive | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 9 | 04049016135975 | FC 1201-18010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 10 | 04049016135968 | FC 1201-18010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 11 | 04049016135951 | FC 1201-18010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 12 | 04049016135944 | FC 1201-18010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 13 | 04049016135937 | FC 1201-18010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 14 | 04049016135920 | FC 1201-12010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 15 | 04049016135913 | FC 1201-2450-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 16 | 04049016135906 | FC 1201-1050-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 17 | 04049016135890 | FC 1201-12010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 18 | 04049016135883 | FC 1201-2450-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 19 | 04049016135876 | FC 1201-2450-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 20 | 04049016135869 | FC 1201-12010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 21 | 04049016135852 | FC 1201-1050-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 22 | 04049016135845 | FC 1201-12010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 23 | 04049016135838 | FC 1201-2450-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 24 | 04049016135821 | FC 1201-1050-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 25 | 04049016135814 | FC 1201-2450-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 26 | 04049016135807 | FC 1201-1050-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 27 | 04049016121497 | FC 1201-12010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 28 | 04049016121473 | FA 1201-12010-4 | IFA: Granulocyte Mosaic 4 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 29 | 04049016119920 | FC 1201-1050-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 30 | 04049016108962 | FC 1201-2010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 31 | 04049016108955 | FC 1201-2005-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 32 | 04049016108948 | FC 1201-1010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 33 | 04049016108931 | FC 1201-1005-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 34 | 04049016108863 | FC 1201-2010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 35 | 04049016108856 | FC 1201-2005-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 36 | 04049016108849 | FC 1201-1010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 37 | 04049016108832 | FC 1201-1005-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 38 | 04049016108764 | FC 1201-2010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 39 | 04049016108757 | FC 1201-2005-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 40 | 04049016108740 | FC 1201-1010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 41 | 04049016108733 | FC 1201-1005-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 42 | 04049016108665 | FC 1201-2010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 43 | 04049016108658 | FC 1201-2005-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 44 | 04049016108641 | FC 1201-1010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 45 | 04049016108634 | FC 1201-1005-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 46 | 04049016108566 | FC 1201-2010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 47 | 04049016108559 | FC 1201-2005-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 48 | 04049016108542 | FC 1201-1010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 49 | 04049016108535 | FC 1201-1005-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 50 | 04049016103233 | FA 1200-18010 | IFA: Granulocytes (EOH) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG |