{
  "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": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OAM",
      "openfda": {
        "k_number": [
          "K061886",
          "K123986"
        ],
        "registration_number": [
          "3012526002",
          "3024463179",
          "3013143953",
          "2029372",
          "3016733849",
          "8021924",
          "3007118747",
          "3005360469",
          "3016837106",
          "1000212994",
          "3009335633",
          "3031915160"
        ],
        "fei_number": [
          "3012526002",
          "3024463179",
          "3013143953",
          "3016733849",
          "3005670738",
          "1000212994",
          "3007118747",
          "3016837106",
          "1000306617",
          "3002485711",
          "3009335633",
          "3031915160"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "Immunoassay, Insulin-Like Growth Factor Binding Protein-1",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "1",
      "definition": "The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions.  The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.",
      "regulation_number": "862.1550",
      "implant_flag": "N",
      "submission_type_id": "4"
    }
  ]
}