{
  "format": "devicerts.device.v1",
  "cite_as": "LIFECODES LSA Class I, Immucor GTI Diagnostics, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/lifecodes-lsa-class-i-265100 (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/lifecodes-lsa-class-i-265100",
    "json_url": "https://devicerts.com/devices/lifecodes-lsa-class-i-265100.json",
    "markdown_url": "https://devicerts.com/devices/lifecodes-lsa-class-i-265100.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-11-08",
    "status_as_of": "2026-11-14",
    "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/lifecodes-lsa-class-i-265100",
    "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": "LIFECODES LSA Class I",
    "registry_name": "LIFECODES LSA Class I",
    "url": "https://devicerts.com/devices/lifecodes-lsa-class-i-265100",
    "manufacturer": {
      "name": "Immucor GTI Diagnostics, Inc",
      "url": "https://devicerts.com/manufacturers/immucor-gti-diagnostics-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union"
    },
    "classification": [
      {
        "class": "Class C",
        "system": "EU IVDR"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "10850079505152",
            "registries": [
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            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "08500795055A9Y",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [],
    "emdn": [
      {
        "code": "W01030402",
        "term": "HLA ANTIBODY SCREENING"
      }
    ],
    "gmdn": [],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/IVDR",
      "number": "08500795055A9Y",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "10850079505152",
      "date": "2026-11-04",
      "date_kind": "registered",
      "decision_code": null,
      "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": "Identity",
      "fields": [
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "265100",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
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      "group": "Identifiers",
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        {
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          "label": "EMDN code",
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              "value": "W01030402",
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          ]
        }
      ]
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    {
      "group": "Classification",
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          "label": "Device class",
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            {
              "value": "Class C",
              "registries": [
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            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Standard device",
              "registries": [
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              ]
            }
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        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Germany",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
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        {
          "label": "Contains human tissues or cells",
          "values": [
            {
              "value": "Yes",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Contains animal tissues or cells",
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              "registries": [
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        },
        {
          "label": "Reagent",
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            {
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              "registries": [
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              ]
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          ]
        },
        {
          "label": "IVD kit",
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            {
              "value": "Yes",
              "registries": [
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              ]
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          ]
        },
        {
          "label": "Professional testing",
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            {
              "value": "Yes",
              "registries": [
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          ]
        },
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Sterilise before use",
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            {
              "value": "No",
              "registries": [
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          ]
        },
        {
          "label": "Contains substances of microbial origin",
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              "registries": [
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          "label": "Self-testing",
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        {
          "label": "Near-patient testing",
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        {
          "label": "Companion diagnostics",
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          "label": "IVD instrument",
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        {
          "label": "New device",
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            {
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              "registries": [
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          ]
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      ]
    }
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}