{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 14
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "For Ketone test",
      "public_device_record_key": "5fe79ef0-851c-4942-ac6e-21a0fa21b01f",
      "has_serial_number": "false",
      "public_version_date": "2024-07-19",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "004340807",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00816042014376",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "L1 Control Solution (FORA/gojji)",
      "has_manufacturing_date": "false",
      "brand_name": "FORA",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "JJX",
          "name": "Single (Specified) Analyte Controls (Assayed And Unassayed)",
          "openfda": {
            "device_name": "Single (Specified) Analyte Controls (Assayed And Unassayed)",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1660",
            "device_class": "1"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "true",
      "company_name": "FORA CARE INC.",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "53340",
          "name": "Ketone (acetoacetate) IVD, control",
          "definition": "A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of ketone (acetoacetate) in a clinical specimen.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2023-07-07"
    }
  ]
}