{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "proprietary_name": [
        "CyFlow CD7 PE-Cy7",
        "CyFlow IgG (Fab) PE-Cy7",
        "CyFlow CD11c FITC",
        "CyFlow CD200 PE-Cy7",
        "CyFlow HLA-DR APC-Cy7",
        "CyFlow CD25 PE",
        "CyFlow CD8 PerCP",
        "CyFlow CD4 PerCP-Cy5.5",
        "CyFlow CD20 Pacific Blue",
        "CyFlow MPO FITC",
        "CyFlow CD10 PE",
        "CyFlow CD19 PerCP-Cy5.5",
        "CyFlow CD8 Pacific Blue",
        "CyFlow Kappa-LC Pacific Blue",
        "CyFlow Lambda-LC APC",
        "CyFlow CD5 APC",
        "CyFlow CD22 APC",
        "CyFlow CD5 Pacific Blue",
        "CyFlow CD38 FITC",
        "CyFlow CD13 PE",
        "CyFlow CD4 FITC",
        "CyFlow CD10 APC",
        "CyFlow CD41 PE",
        "CyFlow CD22 PE",
        "CyFlow CD4 APC",
        "CyFlow Kappa-LC PE",
        "CyFlow CD3 Pacific Blue",
        "CyFlow CD3 FITC",
        "CyFlow CD38 Pacific Blue",
        "CyFlow CD25 FITC",
        "CyFlow CD13 APC",
        "CyFlow CD103 FITC",
        "CyFlow CD79a PE",
        "CyFlow CD8 Pacific Orange",
        "CyFlow CD16 PerCP",
        "CyFlow CD16 FITC",
        "CyFlow CD33 PerCP-Cy5.5",
        "CyFlow CD38 PE",
        "CyFlow CD3 APC",
        "CyFlow Kappa-LC APC",
        "CyFlow CD235a FITC",
        "CyFlow CD16 Pacific Orange",
        "CyFlow CD117 FITC",
        "CyFlow CD27 PE",
        "CyFlow CD13 FITC",
        "CyFlow CD45 Pacific Orange",
        "CyFlow CD41 APC",
        "CyFlow CD33 APC",
        "CyFlow CD3 APC-Cy7",
        "CyFlow CD45 FITC",
        "CyFlow CD4 Pacific Blue",
        "CyFlow CD16 APC",
        "CyFlow CD8 PE",
        "CyFlow CD19 PE-Cy7",
        "CyFlow CD56 PerCP-Cy5.5",
        "CyFlow CD41 FITC",
        "CyFlow CD16 PE",
        "CyFlow CD10 Alexa Fluor 700",
        "CyFlow CD20 APC",
        "CyFlow CD33 PE",
        "CyFlow CD8 Alexa Fluor 700",
        "CyFlow Lambda-LC PE",
        "CyFlow CD45 Pacific Blue",
        "CyFlow CD8 FITC",
        "CyFlow CD19 PE",
        "CyFlow CD20 PerCP-Cy5.5",
        "CyFlow CD27 FITC",
        "CyFlow CD33 FITC",
        "CyFlow CD19 APC",
        "CyFlow CD8 PerCP-Cy5.5",
        "CyFlow CD10 FITC",
        "CyFlow CD56 PE",
        "CyFlow CD19 Alexa Fluor 700",
        "CyFlow CD5 FITC",
        "CyFlow CD24 APC",
        "CyFlow CD11b FITC",
        "CyFlow CD10 APC-Cy7",
        "CyFlow CD4 PE-Cy7",
        "CyFlow CD61 FITC",
        "CyFlow CD25 APC",
        "CyFlow CD71 APC-Cy7",
        "CyFlow CD11b PE-Cy7",
        "CyFlow MPO PE",
        "CyFlow CD2 Pacific Blue",
        "CyFlow CD13 PE-Cy7",
        "CyFlow CD2 APC",
        "CyFlow CD235a PE",
        "CyFlow Lambda-LC FITC",
        "CyFlow CD56 FITC",
        "CyFlow CD117 PE",
        "CyFlow CD45 APC",
        "CyFlow CD19 PE-DyLight 594",
        "CyFlow CD20 PE",
        "CyFlow CD117 APC-Cy7",
        "CyFlow CD4 PE",
        "CyFlow CD8 APC",
        "CyFlow CD45 APC-Cy7",
        "CyFlow CD45 PE-Cy7",
        "CyFlow Kappa-LC FITC",
        "CyFlow CD3 Alexa Fluor 700",
        "CyFlow CD5 PE-Cy7",
        "CyFlow CD33 PE-Cy7",
        "CyFlow CD38 PerCP-Cy5.5",
        "CyFlow CD23 PE",
        "CyFlow CD200 APC",
        "CyFlow CD123 FITC",
        "CyFlow CD117 PE-Cy7",
        "CyFlow CD5 PerCP-Cy5.5",
        "CyFlow CD7 PerCP-Cy5.5",
        "CyFlow CD10 PE-DyLight 594",
        "CyFlow CD1a PE",
        "CyFlow CD8 APC-Cy7",
        "CyFlow CD4 APC-Cy7",
        "CyFlow CD2 PE-Cy7",
        "CyFlow CD3 PE-DyLight 594",
        "CyFlow CD138 PerCP-Cy5.5",
        "CyFlow CD56 APC",
        "CyFlow CD8 PE-DyLight 594",
        "CyFlow CD117 PerCP-Cy5.5",
        "CyFlow CD200 PE",
        "CyFlow CD71 PE",
        "CyFlow CD23 PE-DyLight 594",
        "CyFlow TCR gamma/delta FITC",
        "CyFlow CD45 PerCP-Cy5.5",
        "CyFlow CD7 Pacific Blue",
        "CyFlow CD2 PE",
        "CyFlow CD20 PE-DyLight 594",
        "CyFlow TCR gamma/delta PE",
        "CyFlow CD21 Pacific Blue",
        "CyFlow CD138 FITC",
        "CyFlow CD103 PE",
        "CyFlow CD157 PE",
        "CyFlow CD7 FITC",
        "CyFlow CD20 PE-Cy7",
        "CyFlow CD27 Pacific Blue",
        "CyFlow CD79a PerCP-Cy5.5",
        "CyFlow CD7 APC",
        "CyFlow CD20 APC-Cy7",
        "CyFlow CD11b Alexa Fluor 700",
        "CyFlow CD16 PE-DyLight 594",
        "CyFlow CD79a APC",
        "CyFlow CD3 PerCP-Cy5.5",
        "CyFlow CD25 Pacific Blue",
        "CyFlow MPO PE-Cy7",
        "CyFlow CD1a APC",
        "CyFlow HLA-DR FITC",
        "CyFlow CD117 Alexa Fluor 700",
        "CyFlow CD34 PE",
        "CyFlow CD11c APC",
        "CyFlow CD24 Alexa Fluor 700",
        "CyFlow CD7 PE",
        "CyFlow CD103 APC",
        "CyFlow CD14 Alexa Fluor 700",
        "CyFlow HLA-DR PE",
        "CyFlow CD56 PE-DyLight 594",
        "CyFlow CD123 PerCP-Cy5.5",
        "CyFlow HLA-DR Pacific Blue",
        "CyFlow CD71 Alexa Fluor 700",
        "CyFlow CD19 FITC",
        "CyFlow CD9 Pacific Blue",
        "CyFlow CD20 FITC",
        "CyFlow CD2 FITC",
        "CyFlow CD13 PerCP-Cy5.5",
        "CyFlow CD14 PE-DyLight 594",
        "CyFlow CD11c PE",
        "CyFlow CD14 Pacific Blue",
        "CyFlow CD14 PE",
        "CyFlow CD14 FITC",
        "CyFlow CD11c APC-Cy7",
        "CyFlow CD7 PE-DyLight 594",
        "CyFlow CD30 APC",
        "CyFlow CD16 PE-Cy7",
        "CyFlow CD38 APC-Cy7",
        "CyFlow CD79a FITC",
        "CyFlow CD3 PE-Cy7",
        "CyFlow CD11c PE-Cy7",
        "CyFlow CD13 PE-DyLight 594",
        "CyFlow HLA-DR Alexa Fluor 700",
        "CyFlow CD138 APC",
        "CyFlow CD64 PE-Cy7",
        "CyFlow CD31 PE",
        "CyFlow Lambda-LC Alexa Fluor 488",
        "CyFlow CD14 PerCP-Cy5.5",
        "CyFlow MPO APC",
        "CyFlow CD43 APC-Cy7",
        "CyFlow CD34 PerCP-Cy5.5",
        "CyFlow CD14 APC",
        "CyFlow CD123 PE",
        "CyFlow CD123 PE-DyLight 594",
        "CyFlow CD34 APC",
        "CyFlow CD34 PE-DyLight 594",
        "CyFlow CD16 Alexa Fluor 700",
        "CyFlow CD138 Pacific Blue",
        "CyFlow CD34 FITC",
        "CyFlow CD24 PE_DyLight 594",
        "CyFlow CD14 APC-Cy7",
        "CyFlow CD34 PE-Cy7",
        "CyFlow CD8 PE-Cy7",
        "CyFlow CD23 APC",
        "CyFlow CD15 FITC",
        "CyFlow CD36 FITC",
        "CyFlow TCR gamma/delta PE-Cy7",
        "CyFlow CD16 Pacific Blue",
        "CyFlow CD19 APC-Cy7",
        "CyFlow Ki-67 PE",
        "CyFlow Kappa-LC Alexa Fluor 488",
        "CyFlow CD64 Alexa Fluor 700",
        "CyFlow CD79b PE",
        "CyFlow CD64 APC-Cy7",
        "CyFlow CD3 PE-Cy5",
        "CyFlow CD45R0 FITC",
        "CyFlow CD64 FITC",
        "CyFlow Perforin PE",
        "CyFlow CD8 PE-Cy5",
        "CyFlow CD23 PerCP-Cy5.5",
        "CyFlow CD22 PerCP-Cy5.5",
        "CyFlow CD5 Alexa Fluor 700",
        "CyFlow IgM PerCP-Cy5.5",
        "CyFlow CD56 PE-Cy7",
        "CyFlow CD28 APC",
        "CyFlow CD34 Pacific Blue",
        "CyFlow CD26 PE",
        "CyFlow CD81 Alexa Fluor 700",
        "CyFlow CD62P Biotin",
        "CyFlow IFN-gamma FITC",
        "CyFlow CD25 PE-Cy5",
        "CyFlow CD11b APC-Cy7",
        "CyFlow TdT FITC",
        "CyFlow CD36 APC",
        "CyFlow CD38 PE-Cy7",
        "CyFlow CD57 FITC",
        "CyFlow IgD PE",
        "CyFlow CD15 Pacific Blue",
        "CyFlow CD305 FITC",
        "CyFlow CD14 PE-Cy7",
        "CyFlow CD10 PE-Cy7",
        "CyFlow CD3 Pacific Orange"
      ],
      "establishment_type": [
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "3005626422",
        "fei_number": "3005626422",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Sysmex Europe SE",
        "address_line_1": "Mainstrasse 7",
        "address_line_2": "",
        "city": "Neumunster Schleswig-Holstein",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "D-24539",
        "us_agent": {
          "name": "Simon C. Shorter",
          "business_name": "SYSMEX AMERICA, INC",
          "bus_phone_area_code": "408",
          "bus_phone_num": "8380220",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "shorters@sysmex.com",
          "address_line_1": "577 APTAKISIC RD",
          "address_line_2": "",
          "city": "Lincolnshire",
          "state_code": "IL",
          "iso_country_code": "US",
          "zip_code": "60069",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "SYSMEX CORPORATION",
          "owner_operator_number": "9014170",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "4-4-4 TAKATSUKADAI",
            "address_2": "NISHI-KU",
            "city": "KOBE",
            "state_code": "JP-NOTA",
            "state_province": "",
            "iso_country_code": "JP",
            "postal_code": "651-2271"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "MVU",
          "created_date": "2017-09-28",
          "owner_operator_number": "9014170",
          "exempt": "",
          "openfda": {
            "device_name": "Reagents, Specific, Analyte",
            "medical_specialty_description": "Pathology",
            "regulation_number": "864.4020",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}