{
  "format": "devicerts.device.v1",
  "cite_as": "AIACT Kit, Sienco, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/aiact-kit-jbp (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/aiact-kit-jbp",
    "json_url": "https://devicerts.com/devices/aiact-kit-jbp.json",
    "markdown_url": "https://devicerts.com/devices/aiact-kit-jbp.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-06",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/aiact-kit-jbp",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "AIACT Kit",
    "registry_name": "AIACT KIT",
    "url": "https://devicerts.com/devices/aiact-kit-jbp",
    "manufacturer": {
      "name": "Sienco, Inc.",
      "url": "https://devicerts.com/manufacturers/sienco-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K032952",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "JBP"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The AIACT Kit is an in vitro diagnostic test for use with Sonoclot® Analyzer Systems. It is a celite/clay blend activated test that provides quantitative ACT and Clot Rate results for high dose heparin management.\n\nThe kit is intended for use with native whole blood and citrated whole blood, and is not affected by aprotinin. It includes cuvettes, probes, instructions for use, and reference plasma quality control. The device is FDA 510(k) cleared with product code JBP.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K032952",
      "number_label": null,
      "device_udi_di": null,
      "date": "2003-12-12",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
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            {
              "value": "K032952",
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                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "JBP",
              "registries": [
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          ]
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    },
    {
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      "fields": [
        {
          "label": "Device class",
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          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 864.7140",
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          ]
        },
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          "label": "Advisory committee",
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            {
              "value": "Hematology",
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              "value": "SESE",
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}