{
  "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": "2026-10-26",
    "results": {
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  "results": [
    {
      "proprietary_name": [
        "MMLV Reverse Transcriptase, 2000 Units",
        "Lyo-Ready PrimePath™ Probe qPCR Mix, 100 rxns",
        "5X PrimePath™ Probe qPCR Kit, no ROX, 200 rxns",
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        "5X One Step PrimeScript™ III RT-qPCR Kit, no ROX, 1000 rxns",
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        "5X PrimePath™ Probe qPCR Kit, ROX plus, 200 rxns",
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        "5X One Step PrimeScript™ III RT-qPCR Kit, ROX plus, 200 rxns",
        "5X PrimePath™ Probe qPCR Kit, ROX plus, 1000 rxns",
        "MMLV Reverse Transcriptase, 8000 Units",
        "5X PrimePath™ Probe qPCR Kit, no ROX, 1000 rxns"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Develop Specifications But Do Not Manufacture At This Facility",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "1000231747",
        "fei_number": "1000231747",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2026",
        "name": "Takara Bio USA, Inc.",
        "address_line_1": "2560 Orchard Parkway",
        "address_line_2": "",
        "city": "San Jose",
        "state_code": "CA",
        "iso_country_code": "US",
        "zip_code": "95131",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Takara Bio USA, Inc.",
          "owner_operator_number": "10049222",
          "official_correspondent": {
            "first_name": "Loretta",
            "middle_initial": "L",
            "last_name": "Momme",
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            "phone_number": "1-650-9197436-x"
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            "address_2": "",
            "city": "San Jose",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "95131"
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        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "PPM",
          "created_date": "2015-04-29",
          "owner_operator_number": "10049222",
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            "medical_specialty_description": "Pathology",
            "regulation_number": "864.4010",
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}