{
  "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": [
    {
      "proprietary_name": [
        "DASH® Negative Control",
        "DASH® Rapid PCR Instrument",
        "DASH® SARS-CoV-2 & Flu A/B Test",
        "DASH® SARS-CoV-2 & Flu A B Positive Control"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3035381641",
        "fei_number": "3035381641",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Nuclein, LLC",
        "address_line_1": "500 Center Ridge Dr Ste 400",
        "address_line_2": "",
        "city": "Austin",
        "state_code": "TX",
        "iso_country_code": "US",
        "zip_code": "78753",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Nuclein, LLC",
          "owner_operator_number": "10092415",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "8305 Cross Park Drive",
            "address_2": "",
            "city": "Austin",
            "state_code": "TX",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "78754"
          }
        }
      },
      "pma_number": "",
      "k_number": "K241652",
      "products": [
        {
          "product_code": "NSU",
          "created_date": "2025-01-03",
          "owner_operator_number": "10092415",
          "exempt": "",
          "openfda": {
            "device_name": "Instrumentation For Clinical Multiplex Test Systems",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2570",
            "device_class": "2"
          }
        },
        {
          "product_code": "QOF",
          "created_date": "2025-01-03",
          "owner_operator_number": "10092415",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K241652"
            ],
            "device_name": "Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3981",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}