{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Affymetrix, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/affymetrix-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/affymetrix-inc",
    "json_url": "https://devicerts.com/manufacturers/affymetrix-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/affymetrix-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "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/manufacturers/affymetrix-inc",
    "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."
  },
  "manufacturer": {
    "name": "Affymetrix, Inc.",
    "url": "https://devicerts.com/manufacturers/affymetrix-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000028847"
      },
      {
        "label": "FDA FEI",
        "value": "3003314809"
      },
      {
        "label": "DUNS",
        "value": "804682573"
      }
    ],
    "summary": "Affymetrix, Inc. is a medical device manufacturer based in the United States, with 20 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class C and A; FDA Class II) and 2 FDA recalls as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 20,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 2,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 17
      },
      {
        "registry": "EUDAMED",
        "devices": 12
      },
      {
        "registry": "FDA 510(k)",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "EU Class C",
        "devices": 9
      },
      {
        "class": "FDA Class II",
        "devices": 8
      },
      {
        "class": "EU Class A",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "W01",
        "name": "Reagents",
        "url": "https://devicerts.com/categories/emdn/W01",
        "devices": 8
      },
      {
        "code": "W02",
        "name": "IVD instruments",
        "url": "https://devicerts.com/categories/emdn/W02",
        "devices": 4
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Life Technologies Europe B.V.",
        "url": "https://devicerts.com/representatives/life-technologies-europe-bv-nl-ar-000021890",
        "country": "Netherlands"
      }
    ]
  },
  "devices": {
    "shown": 20,
    "total": 20,
    "all_devices_url": "https://devicerts.com/manufacturers/affymetrix-inc",
    "items": [
      {
        "name": "Affymetrix 00-0146",
        "url": "https://devicerts.com/devices/affymetrix-00-0146",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Affymetrix 1.2",
        "url": "https://devicerts.com/devices/affymetrix-610525",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Affymetrix 520969",
        "url": "https://devicerts.com/devices/affymetrix-520969",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Affymetrix 1.2",
        "url": "https://devicerts.com/devices/affymetrix-610466",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Affymetrix 2.1",
        "url": "https://devicerts.com/devices/affymetrix-610533",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Affymetrix Gene Profiling Reagents",
        "url": "https://devicerts.com/devices/affymetrix-gene-profiling-reagents-ova",
        "model_reference": "K103112",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2011-05-04",
        "open_recall": false
      },
      {
        "name": "Modification To Affymetrix Genechip Microarray Instrumentation System",
        "url": "https://devicerts.com/devices/modification-to-affymetrix-genechip-microarray-instrumentati-nsu",
        "model_reference": "K080995",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2008-07-30",
        "open_recall": false
      },
      {
        "name": "Affymetrix Genechip Microarray Instrumentation System",
        "url": "https://devicerts.com/devices/affymetrix-genechip-microarray-instrumentation-system-nsu",
        "model_reference": "DEN040012",
        "device_class": "Class II",
        "registries": [
          "De Novo"
        ],
        "status": "Active",
        "decision_date": "2004-12-23",
        "open_recall": false
      },
      {
        "name": "CytoScan Dx Post-PCR 15°-30°C MOD E PW",
        "url": "https://devicerts.com/devices/cytoscan-dx-post-pcr-15deg-30degc-mod-e-pw-902111-902420",
        "model_reference": "902111 (902420)",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "GeneChip™ Scanner 3000Dx v.2 with AutoLoaderDx v2",
        "url": "https://devicerts.com/devices/genechip-scanner-3000dx-v-2-with-autoloaderdx-v2-00-0336-00-0334",
        "model_reference": "00-0336 (00-0334)",
        "device_class": "Class A",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CytoScan Dx Pre-PCR -20°C MOD R L A",
        "url": "https://devicerts.com/devices/cytoscan-dx-pre-pcr-20degc-mod-r-l-a-902107-902420",
        "model_reference": "902107 (902420)",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CytoScan Dx Post-PCR -20°C MOD F L H",
        "url": "https://devicerts.com/devices/cytoscan-dx-post-pcr-20degc-mod-f-l-h-902109-902420",
        "model_reference": "902109 (902420)",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CytoScan Dx Wash Solution B",
        "url": "https://devicerts.com/devices/cytoscan-dx-wash-solution-b-902091-902420",
        "model_reference": "902091 (902420)",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "GeneChip™ Fluidics Station FS450Dx v.2",
        "url": "https://devicerts.com/devices/genechip-fluidics-station-fs450dx-v-2-00-0335-00-0334",
        "model_reference": "00-0335 (00-0334)",
        "device_class": "Class A",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "GCDC Dx Installer v1.0",
        "url": "https://devicerts.com/devices/gcdc-dx-installer-v1-0-611403-00-0334",
        "model_reference": "611403 (00-0334)",
        "device_class": "Class A",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CytoScan Dx Pre-PCR 2°-8°C MOD T E W",
        "url": "https://devicerts.com/devices/cytoscan-dx-pre-pcr-2-8-c-mod-t-e-w-902108-902420",
        "model_reference": "902108 (902420)",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CytoScan Dx Post-PCR 2°-8°C MOD S AH W PB",
        "url": "https://devicerts.com/devices/cytoscan-dx-post-pcr-2-8-c-mod-s-ah-w-pb-902110-902420",
        "model_reference": "902110 (902420)",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CytoScan Dx Wash Solution A",
        "url": "https://devicerts.com/devices/cytoscan-dx-wash-solution-a-902090-902420",
        "model_reference": "902090 (902420)",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Chromosome Analysis Suite Dx Software (ChAS Dx)",
        "url": "https://devicerts.com/devices/chromosome-analysis-suite-dx-software-chas-dx-610525",
        "model_reference": "610525",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CytoScan Dx Array, 6 pk",
        "url": "https://devicerts.com/devices/cytoscan-dx-array-6-pk-902150-902420",
        "model_reference": "902150 (902420)",
        "device_class": "Class C",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1909-2016",
      "classification": "Class III",
      "status": "Terminated",
      "initiated": "2016-04-14",
      "product_code": "PFX",
      "reason": "During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment."
    },
    {
      "number": "Z-0853-06",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2005-04-26",
      "product_code": "NSU",
      "reason": "Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or during a run."
    }
  ]
}