{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Roche Diagnostics Corp. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/roche-diagnostics-corp (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/roche-diagnostics-corp",
    "json_url": "https://devicerts.com/manufacturers/roche-diagnostics-corp.json",
    "markdown_url": "https://devicerts.com/manufacturers/roche-diagnostics-corp.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA PMA",
        "url": "https://open.fda.gov/apis/device/pma/"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "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/roche-diagnostics-corp",
    "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": "Roche Diagnostics Corp.",
    "url": "https://devicerts.com/manufacturers/roche-diagnostics-corp",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Roche Diagnostics",
      "Roche Diagnostics Corporation",
      "Roche Diagnostics, Inc."
    ],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [],
    "summary": "Roche Diagnostics Corp. is a medical device manufacturer, with 469 devices listed in FDA 510(k), FDA PMA and FDA GUDID (FDA Class II, Class I, Unclassified and Class III) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 469,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "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 510(k)",
        "devices": 454
      },
      {
        "registry": "FDA PMA",
        "devices": 15
      },
      {
        "registry": "FDA GUDID",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 359
      },
      {
        "class": "FDA Class I",
        "devices": 104
      },
      {
        "class": "FDA Unclassified",
        "devices": 5
      },
      {
        "class": "FDA Class III",
        "devices": 1
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 469,
    "all_devices_url": "https://devicerts.com/manufacturers/roche-diagnostics-corp",
    "items": [
      {
        "name": "Coaguchek Xs System",
        "url": "https://devicerts.com/devices/coaguchek-xs-system-gjs",
        "model_reference": "K062925",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2007-01-29",
        "open_recall": false
      },
      {
        "name": "cobas pulse blood glucose monitoring system",
        "url": "https://devicerts.com/devices/cobas-pulse-blood-glucose-monitoring-system-pzi-k252323",
        "model_reference": "K252323",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-06-12",
        "open_recall": false
      },
      {
        "name": "Elecsys EBV IgM",
        "url": "https://devicerts.com/devices/elecsys-ebv-igm-ljn",
        "model_reference": "K260233",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-10-02",
        "open_recall": false
      },
      {
        "name": "Elecsys EBV VCA IgG",
        "url": "https://devicerts.com/devices/elecsys-ebv-vca-igg-lse",
        "model_reference": "K260232",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-10-02",
        "open_recall": false
      },
      {
        "name": "Elecsys EBV EBNA IgG",
        "url": "https://devicerts.com/devices/elecsys-ebv-ebna-igg-lse",
        "model_reference": "K260221",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-10-02",
        "open_recall": false
      },
      {
        "name": "Elecsys Phospho-Tau (217P) Plasma",
        "url": "https://devicerts.com/devices/elecsys-phospho-tau-217p-plasma-set",
        "model_reference": "K261686",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-08-19",
        "open_recall": false
      },
      {
        "name": "Modification To:cobas Integra Hdl-Cholesterol Plus 2ND Generation",
        "url": "https://devicerts.com/devices/modification-to-cobas-integra-hdl-cholesterol-plus-2nd-gener-lbs",
        "model_reference": "K012286",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-08-08",
        "open_recall": false
      },
      {
        "name": "Preciset Dat Amphetamine Calibrators; Cfas Dat Qualitative Amphetamine Calibrators",
        "url": "https://devicerts.com/devices/preciset-dat-amphetamine-calibrators-cfas-dat-qualitative-am-dlj",
        "model_reference": "K033165",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2003-10-14",
        "open_recall": false
      },
      {
        "name": "Elecsys Probnp Ii, Precicontrol Cardiac Ii, Probnp Ii Calset",
        "url": "https://devicerts.com/devices/elecsys-probnp-ii-precicontrol-cardiac-ii-probnp-ii-calset-nbc",
        "model_reference": "K072437",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2008-02-05",
        "open_recall": false
      },
      {
        "name": "Roche Elecsys Anti-Tg",
        "url": "https://devicerts.com/devices/roche-elecsys-anti-tg-jzo",
        "model_reference": "K053426",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2006-02-07",
        "open_recall": false
      },
      {
        "name": "Elecsys Anti-Tpo Calcheck",
        "url": "https://devicerts.com/devices/elecsys-anti-tpo-calcheck-jjx",
        "model_reference": "K001014",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2000-06-01",
        "open_recall": false
      },
      {
        "name": "Elecsys Rubella Igg Calcheck",
        "url": "https://devicerts.com/devices/elecsys-rubella-igg-calcheck-jjx",
        "model_reference": "K090311",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2009-05-05",
        "open_recall": false
      },
      {
        "name": "Roche Diagnostics Cobas Integra Albumin Gen. 2",
        "url": "https://devicerts.com/devices/roche-diagnostics-cobas-integra-albumin-gen-2-cix",
        "model_reference": "K033009",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2003-10-16",
        "open_recall": false
      },
      {
        "name": "Elecsys HSV-2 IgG (08948887160)",
        "url": "https://devicerts.com/devices/elecsys-hsv-2-igg-08948887160-myf",
        "model_reference": "K220924",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2022-10-12",
        "open_recall": false
      },
      {
        "name": "Elecsys Syphilis",
        "url": "https://devicerts.com/devices/elecsys-syphilis-lip-k160910",
        "model_reference": "K160910",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2016-07-28",
        "open_recall": false
      },
      {
        "name": "Roche Elecsys Troponin T Stat (Short Turnaround Time)",
        "url": "https://devicerts.com/devices/roche-elecsys-troponin-t-stat-short-turnaround-time-mmi",
        "model_reference": "K051752",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2005-07-11",
        "open_recall": false
      },
      {
        "name": "Elecsys Ige Calcheck 5",
        "url": "https://devicerts.com/devices/elecsys-ige-calcheck-5-jjx",
        "model_reference": "K102269",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2010-10-07",
        "open_recall": false
      },
      {
        "name": "Accu-Chek Aviva Test Strips",
        "url": "https://devicerts.com/devices/accu-chek-aviva-test-strips-nbw",
        "model_reference": "K060620",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2006-08-11",
        "open_recall": false
      },
      {
        "name": "Modification To Reflotron Amylase, Cat. 1200658",
        "url": "https://devicerts.com/devices/modification-to-reflotron-amylase-cat-1200658-jfj",
        "model_reference": "K011145",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-06-25",
        "open_recall": false
      },
      {
        "name": "Elecsys Hcg Stat Claset Ii",
        "url": "https://devicerts.com/devices/elecsys-hcg-stat-claset-ii-jis",
        "model_reference": "K003941",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-01-25",
        "open_recall": false
      },
      {
        "name": "Modification To Elecsys Fsh Ii Calset",
        "url": "https://devicerts.com/devices/modification-to-elecsys-fsh-ii-calset-jit",
        "model_reference": "K012399",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-08-24",
        "open_recall": false
      },
      {
        "name": "Chemstrip 5 Ob, Chemstrip 7 And Chemstrip 10 Md Test Strips",
        "url": "https://devicerts.com/devices/chemstrip-5-ob-chemstrip-7-and-chemstrip-10-md-test-strips-jil",
        "model_reference": "K032437",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2003-10-08",
        "open_recall": false
      },
      {
        "name": "Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323",
        "url": "https://devicerts.com/devices/tina-quant-soluble-transferrin-receptor-test-system-hitachi-ddg",
        "model_reference": "K003064",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-05-01",
        "open_recall": false
      },
      {
        "name": "Elecsys Anti-TSHR",
        "url": "https://devicerts.com/devices/elecsys-anti-tshr-jzo",
        "model_reference": "K193313",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2020-02-27",
        "open_recall": true
      },
      {
        "name": "Ise Indirect Na, K, C1 For Gen 2",
        "url": "https://devicerts.com/devices/ise-indirect-na-k-c1-for-gen-2-jgs",
        "model_reference": "K140373",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2014-05-22",
        "open_recall": false
      },
      {
        "name": "Ceruloplasmin, Model 2055953",
        "url": "https://devicerts.com/devices/ceruloplasmin-model-2055953-chn",
        "model_reference": "K062114",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2007-01-31",
        "open_recall": false
      },
      {
        "name": "Tina-Quant Hemoglobin A1C GEN.2 Test",
        "url": "https://devicerts.com/devices/tina-quant-hemoglobin-a1c-gen-2-test-lcp",
        "model_reference": "K052464",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2005-09-30",
        "open_recall": false
      },
      {
        "name": "Elecsys Anti-Tpo Calset",
        "url": "https://devicerts.com/devices/elecsys-anti-tpo-calset-jix",
        "model_reference": "K103171",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2011-02-11",
        "open_recall": false
      },
      {
        "name": "Online Phenobarbital, Model 03016757190 & 03510620",
        "url": "https://devicerts.com/devices/online-phenobarbital-model-03016757190-and-03510620-dlz",
        "model_reference": "K071644",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2007-09-12",
        "open_recall": false
      },
      {
        "name": "Elecsys sFlt-1 and Elecsys PlGF",
        "url": "https://devicerts.com/devices/elecsys-sflt-1-and-elecsys-plgf-qwh",
        "model_reference": "K241453",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-02-07",
        "open_recall": false
      },
      {
        "name": "Coaguchek Xs Pt Controls",
        "url": "https://devicerts.com/devices/coaguchek-xs-pt-controls-ggn",
        "model_reference": "K063823",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2007-01-29",
        "open_recall": false
      },
      {
        "name": "Elecsys CYFRA 21-1 CalCheck 5",
        "url": "https://devicerts.com/devices/elecsys-cyfra-21-1-calcheck-5-jjx",
        "model_reference": "K162173",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-01-12",
        "open_recall": false
      },
      {
        "name": "Oral Fluid Phencyclidine",
        "url": "https://devicerts.com/devices/oral-fluid-phencyclidine-lcm",
        "model_reference": "K093989",
        "device_class": "Unclassified",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2011-01-25",
        "open_recall": false
      },
      {
        "name": "Elecsys Toxo Igg Calcheck",
        "url": "https://devicerts.com/devices/elecsys-toxo-igg-calcheck-jjx",
        "model_reference": "K083655",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2009-02-12",
        "open_recall": false
      },
      {
        "name": "Calcium Gen. 2",
        "url": "https://devicerts.com/devices/calcium-gen-2-chw",
        "model_reference": "K113521",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2012-05-08",
        "open_recall": false
      },
      {
        "name": "Act Test Catridges For Coaguchek Pro System, Act Controls For Coaguchek Pro System",
        "url": "https://devicerts.com/devices/act-test-catridges-for-coaguchek-pro-system-act-controls-for-jbp",
        "model_reference": "K992851",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2000-01-14",
        "open_recall": false
      },
      {
        "name": "Elecsys Testosterone Ii Immunoassay",
        "url": "https://devicerts.com/devices/elecsys-testosterone-ii-immunoassay-cdz",
        "model_reference": "K093421",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2010-04-23",
        "open_recall": false
      },
      {
        "name": "Cobas Integra Carbon Dioxide Assay",
        "url": "https://devicerts.com/devices/cobas-integra-carbon-dioxide-assay-khs",
        "model_reference": "K031879",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2003-07-17",
        "open_recall": false
      },
      {
        "name": "Elecsys AMH",
        "url": "https://devicerts.com/devices/elecsys-amh-pqo",
        "model_reference": "K203757",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2022-06-10",
        "open_recall": false
      },
      {
        "name": "Elecsys Hcg Stat Calcheck 5",
        "url": "https://devicerts.com/devices/elecsys-hcg-stat-calcheck-5-jjx",
        "model_reference": "K093700",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2010-03-04",
        "open_recall": false
      },
      {
        "name": "Abuscreen Online Opiates 300 / 2000",
        "url": "https://devicerts.com/devices/abuscreen-online-opiates-300-2000-djg",
        "model_reference": "K013482",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2001-12-21",
        "open_recall": false
      },
      {
        "name": "Tina-Quant Apolipoprotein B VER.2",
        "url": "https://devicerts.com/devices/tina-quant-apolipoprotein-b-ver-2-dfc-k013206",
        "model_reference": "K013206",
        "device_class": "Class II",
        "registries": [
          "510(k)",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": "2001-11-16",
        "open_recall": false
      },
      {
        "name": "Elecsys FT4 III",
        "url": "https://devicerts.com/devices/elecsys-ft4-iii-cec",
        "model_reference": "K181233",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-09-18",
        "open_recall": false
      },
      {
        "name": "Ontrak Testcup 501, Model 3016633",
        "url": "https://devicerts.com/devices/ontrak-testcup-501-model-3016633-dkz",
        "model_reference": "K001421",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2000-07-12",
        "open_recall": false
      },
      {
        "name": "Ontrak Testcup Pro-5, Model 1986678",
        "url": "https://devicerts.com/devices/ontrak-testcup-pro-5-model-1986678-djc",
        "model_reference": "K001356",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2000-07-10",
        "open_recall": false
      },
      {
        "name": "Tina-Quant HBA1C GEN.2",
        "url": "https://devicerts.com/devices/tina-quant-hba1c-gen-2-lcp",
        "model_reference": "K110313",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2011-12-23",
        "open_recall": false
      },
      {
        "name": "Roche Diagnostics Calibrator For Automated Systems, Roche Diagnostics Calibrator Calibrator For Automated System",
        "url": "https://devicerts.com/devices/roche-diagnostics-calibrator-for-automated-systems-roche-dia-jix",
        "model_reference": "K101456",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2010-09-08",
        "open_recall": false
      },
      {
        "name": "Ontrak Testcup-Er M2K",
        "url": "https://devicerts.com/devices/ontrak-testcup-er-m2k-dkz",
        "model_reference": "K990418",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1999-04-13",
        "open_recall": false
      },
      {
        "name": "Elecsys C-Peptide Calcheck 5",
        "url": "https://devicerts.com/devices/elecsys-c-peptide-calcheck-5-jjx",
        "model_reference": "K100810",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2010-04-26",
        "open_recall": false
      },
      {
        "name": "Elecsys Insulin Calset",
        "url": "https://devicerts.com/devices/elecsys-insulin-calset-jis",
        "model_reference": "K001906",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2000-07-13",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}