{ "format": "devicerts.device.v1", "cite_as": "Alinity 08P6201, Abbott. deviCERTS medical device catalogue. https://devicerts.com/devices/alinity-08p6201 (data as of 2026-11-14).", "source": { "canonical_url": "https://devicerts.com/devices/alinity-08p6201", "json_url": "https://devicerts.com/devices/alinity-08p6201.json", "markdown_url": "https://devicerts.com/devices/alinity-08p6201.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" } ], "registry_records_last_synced": "2026-11-07", "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/alinity-08p6201", "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": "Alinity 08P6201", "registry_name": "Alinity 08P6201", "url": "https://devicerts.com/devices/alinity-08p6201", "manufacturer": { "name": "Abbott", "url": "https://devicerts.com/manufacturers/abbott", "country": null, "country_basis": null, "fda_registration_country": "Germany" }, "status": { "state": "active", "label": "Active", "detail": "European Union" }, "classification": [ { "class": "IVD General", "system": "EU IVDD" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "08P6201", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "00380740151089", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00380740151089", "registries": [ "EUDAMED" ] } ] } ], "product_codes": [ "JIX" ], "emdn": [ { "code": "W0102152203", "term": "SPECIFIC PROTEIN STANDARDS AND CALIBRATORS" } ], "gmdn": [ { "code": "30505", "term": "Plasma protein IVD, calibrator" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/IVDD", "number": "B-00380740151089", "number_label": "Basic UDI-DI", "device_udi_di": "00380740151089", "date": "2026-11-02", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "00380740151089", "number_label": "UDI-DI", "device_udi_di": null, "date": "2018-10-22", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [], "recalls": [], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "Alinity", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Plasma protein IVD, calibrator", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Device name", "values": [ { "value": "Specific Protein Multiconstituent Calibrator", "registries": [ "EUDAMED" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "08P6201", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00380740151089", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00380740151089", "registries": [ "EUDAMED" ] } ] }, { "label": "FDA product code", "values": [ { "value": "JIX", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "W0102152203", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Plasma protein IVD, calibrator", "code": "30505", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IVD General", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "862.1150", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Germany", "registries": [ "EUDAMED" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Contains human tissues or cells", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Reagent", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "IVD kit", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Professional testing", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Prescription use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": 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] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains substances of microbial origin", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Self-testing", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Near-patient testing", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Companion diagnostics", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "IVD instrument", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "New device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }