{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Bedford",
      "advisory_committee_description": "Microbiology",
      "address_1": "Priory Business Park",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "GTY",
      "openfda": {
        "registration_number": [
          "3012516456",
          "3012725363",
          "3009335633",
          "",
          "1061932",
          "1119779",
          "3016733849",
          "3013296716",
          "2060833",
          "3005984081",
          "3003750284",
          "3004635103",
          "3021090658",
          "1616487",
          "3023322455",
          "3017772438",
          "3017550662",
          "3034246205",
          "2000007960",
          "3033751096",
          "3010131137",
          "3007886372",
          "2030538",
          "3008517993",
          "2435505",
          "3005641941",
          "3033507883",
          "2030633",
          "1649661",
          "3016252795",
          "3003917514",
          "3002792284",
          "2531491",
          "2246703",
          "2024674",
          "3007606081",
          "3014150341",
          "3009238284",
          "3006948883",
          "9611882",
          "3024463179",
          "3010852191",
          "3042471840",
          "3005360469",
          "1645225",
          "3004043187",
          "8020790",
          "2027969",
          "2244821"
        ],
        "fei_number": [
          "3012516456",
          "3012725363",
          "3009335633",
          "",
          "3001452245",
          "1119779",
          "1000118544",
          "3016733849",
          "3013296716",
          "3005984081",
          "3003750284",
          "3004635103",
          "3021090658",
          "1616487",
          "3023322455",
          "3017772438",
          "3017550662",
          "3034246205",
          "3000210620",
          "3001451797",
          "2000007960",
          "1000125596",
          "3033751096",
          "3010131137",
          "3007886372",
          "3008517993",
          "3005641941",
          "3033507883",
          "3002808078",
          "3016252795",
          "3003917514",
          "3002792284",
          "2246703",
          "2024674",
          "3005670738",
          "3003516723",
          "3007606081",
          "3014150341",
          "3009238284",
          "3006948883",
          "1000119795",
          "3024463179",
          "3010852191",
          "3042471840",
          "3000203293",
          "1000520007",
          "3004043187",
          "1000611339",
          "2244821"
        ],
        "device_name": "Antigens, All Groups, Streptococcus Spp.",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3740",
        "device_class": "1"
      },
      "zip_code": "MK44 3UP",
      "applicant": "Unipath , Ltd.",
      "decision_date": "2005-12-06",
      "decision_code": "SESE",
      "country_code": "GB",
      "device_name": "INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC",
      "advisory_committee": "MI",
      "contact": "Louise  Roberts",
      "expedited_review_flag": "",
      "k_number": "K051638",
      "state": "",
      "date_received": "2005-06-20",
      "review_advisory_committee": "MI",
      "postal_code": "MK44 3UP",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}