{ "format": "devicerts.device.v1", "cite_as": "BC Validation Kit 10446125, Siemens Healthcare Diagnostics Products Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/bc-validation-kit-oqsc11 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/bc-validation-kit-oqsc11", "json_url": "https://devicerts.com/devices/bc-validation-kit-oqsc11.json", "markdown_url": "https://devicerts.com/devices/bc-validation-kit-oqsc11.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": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-24", "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/bc-validation-kit-oqsc11", "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": "BC Validation Kit 10446125", "registry_name": "BC Validation Kit 10446125", "url": "https://devicerts.com/devices/bc-validation-kit-oqsc11", "manufacturer": { "name": "Siemens Healthcare Diagnostics Products Ltd", "url": "https://devicerts.com/manufacturers/siemens-healthcare-diagnostics-products-ltd", "country": null, "country_basis": null, "fda_registration_country": "Germany" }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class A", "system": "EU IVDR" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "OQSC11", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "00842768008023", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "0405686902118V9", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K970431", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "GKP", "JPA" ], "emdn": [ { "code": "W0202020185", "term": "COAGULOMETERS - CONSUMABLES" } ], "gmdn": [ { "code": "58048", "term": "Optical laboratory instrument performance standard calibrator/control IVD, single-use" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/IVDR", "number": "0405686902118V9", "number_label": "Basic UDI-DI", "device_udi_di": "00842768008023", "date": "2026-07-10", "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": "00842768008023", "number_label": "UDI-DI", "device_udi_di": null, "date": "2016-09-24", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K970431", "number_label": null, "device_udi_di": null, "date": "1997-05-05", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-1435-2021", "classification": "Class II", "status": "terminated", "initiated": "2021-03-02", "reason": "Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.", "applies": "shared submission", "via": "K970431" }, { "number": "Z-0825-2016", "classification": "Class II", "status": "terminated", "initiated": "2016-01-14", "reason": "False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.", "applies": "shared submission", "via": "K970431" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "BC Validation Kit", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Optical laboratory instrument performance standard calibrator/control IVD, single-use", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Device name", "values": [ { "value": "IVDR_27_MAR EB_A_BC_Valid_Kit", "registries": [ "EUDAMED" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "10446125", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] }, { "value": "IVDR_27_MAR EB_A_BC_Valid_Kit", "registries": [ "EUDAMED" ] }, { "value": "OQSC11", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": 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"registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Standard device", "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": "Professional testing", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA 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"Serial number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }