{
  "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": {
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  "results": [
    {
      "proprietary_name": [
        "657197 Synchron AUTO-GLOSS CTS",
        "UniCel DxI Wash Buffer II OnBoard Dilution Kit (A79784 MN MFG)",
        "447650 IMMAGE Immunochemistry Systems BUF 1 Buffer 1",
        "iChem® VELOCITY™ Wash Solution Case of 2 x 7L (800-7217)",
        "445967 SYNCHRON CX Systems Antifoam",
        "PerFix NC Kit (Fixative Reagent)",
        "A28937 SYNCHRON Systems ISE Electrolyte Reference",
        "A88469 HbDIL DxC",
        "447060 IMMAGE Immunochemistry Systems Wash Solution",
        "469110 Synchron Systems NO FOAM",
        "657133 Cartridge Chemistry Wash Solution (CCWA 2 x 300)",
        "447660 IMMAGE Immunochemistry Systems DIL 2 Diluent 2",
        "589784 Trace-Klean Concentrated Cleaning Solution",
        "A28945 SYNCHRON Systems ISE Electrolyte Buffer",
        "447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2",
        "447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3",
        "467826 Sample Diluent 1 DIL1",
        "445865 SYNCHRON Systems Wash Concentrate II",
        "Iris® System Cleanser Pack (800-3203)",
        "447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1",
        "Iris® Diluent Pack (800-3202)",
        "598190 598190 Trace-Klean Ready to Use Cleaning Solution",
        "472137 SYNCHRON and AU Systems Hemolyzing Reagent",
        "447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4",
        "442831 PVT 2,  472055 PVT 5,  442830 PVT 3",
        "DNA Sequencing Separation Buffer",
        "SEPARATION GEL-LPA I",
        "DNA Size Standard Kit - 600",
        "Separation Gel – LPAI",
        "CEQ Sample Loading Solution",
        "DTCS Quick Start Kit",
        "GenomeLab GeXP Start Kit",
        "Sample Loading Solution (SLS)",
        "Separation Buffer",
        "DNA Size Standard Kit - 400",
        "DNA Size Standard Kit - 80",
        "iQ Body Fluids Conical Tubes (800-3215)",
        "66039 Cleaning Solution",
        "664090 CLENZ Solution",
        "iQ Lamina 2 x 7L (800-3236)",
        "iQ Body Fluids Lysing Reagent (800-3213)",
        "Flow Check Pro Fluorospheres",
        "Access Sample Diluent A (P/N: 81908 MN MFG)",
        "Access Wash Buffer II ( P/N: A16972 KY and DE MFG)",
        "Access Substrate (P/N: 81906 MN MFG)",
        "FLOW-CHECK",
        "UniCel DxI Access Wash Buffer II (P/N: A16973 KY and DE MFG)",
        "LumiPhos PRO Substrate (P/N: B96000 MN MFG)",
        "Access Sample Diluent A (Onboard Reagent Kit) (P/N: A79783 MN MFG)",
        "DxFLEX Daily QC Fluorospheres",
        "OSR62166 LIH",
        "OSR0001 WASH SOLUTION",
        "ODR2000 5L WASH SOLUTION"
      ],
      "establishment_type": [
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "3016954941",
        "fei_number": "3016954941",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Beckman Coulter India Private Limited",
        "address_line_1": "Plot No 37/1 Hitech/Defence Aerospace",
        "address_line_2": "IT Sector Mahadevakodigehalli Village,  Hobli Jala Taluk, Bangalore North",
        "city": "Bengaluru (Bangalore) Urban Karnataka",
        "state_code": "",
        "iso_country_code": "IN",
        "zip_code": "",
        "postal_code": "562149",
        "us_agent": {
          "name": "Ian Pilcher",
          "business_name": "Beckman Coulter, Inc.",
          "bus_phone_area_code": "443",
          "bus_phone_num": "3506459",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "ipilcher@beckman.com",
          "address_line_1": "1000 Lake Hazeltine Dr",
          "address_line_2": "",
          "city": "Chaska",
          "state_code": "MN",
          "iso_country_code": "US",
          "zip_code": "55318",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "BECKMAN COULTER, INC.",
          "owner_operator_number": "2050012",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "250 S. Kraemer Blvd",
            "address_2": "--",
            "city": "Brea",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "92821"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "PPM",
          "created_date": "2006-07-24",
          "owner_operator_number": "2050012",
          "exempt": "",
          "openfda": {
            "device_name": "General Purpose Reagent",
            "medical_specialty_description": "Pathology",
            "regulation_number": "864.4010",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}