Basic Information
- Number
- HX 1512506-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- April 17, 2024
- Expiry Date
- July 28, 2026
- Revision
- Rev. 5.1
- Manufacturer
- Siemens Healthcare Diagnostics Products GmbH
Certificate Lifecycle
Scopes
8 scopes covering 2 risk classes
Quality Procedure Scope
IVR 602 W01020101 - IMMUNOGLOBULINS (WITHOUT IGE) W01020102 - COMPLEMENT COMPONENTS W01020103 - TRANSPORT PROTEINS W01020104 - LIPOPROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01020201 - IMMUNOGLOBULIN E - TOTAL W01020701 - ANEMIA W01021104 - ANTI-STREPTOLYSIN O (QUANTITATIVE) W01021110 - RHEUMATOID FACTORS W01021199 - RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER W01021304 - MYOGLOBIN W01021307 - HOMOCYSTEINE W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
IVR 605 W01020807 - AUTOIMMUNE DISEASE TDM W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
IVR 605 W01020807 - AUTOIMMUNE DISEASE TDM W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
IVR 602 W01030202 - COAGULATION FACTORS W01030204 - PLATELET FACTORS W01030205 - FIBRINOLYSIS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
Quality Procedure Scope
IVR 602 W01020103 - TRANSPORT PROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01021308 - HIGH-SENSITIVITY C.REACTIVE PROTEIN (HC-PRC) W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
IVR 301 W01020101 - IMMUNOGLOBULINS (WITHOUT IGE) W01020390 - OTHER TUMOUR MARKERS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
IVR 602 W01030201 - GENERAL COAGULATION TESTS W01030202 - COAGULATION FACTORS W01030203 - SPECIAL COAGULATION TESTS W01030205 - FIBRINOLYSIS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
Quality Procedure Scope
IVR 605 W01030201 - GENERAL COAGULATION TESTS W01030203 - SPECIAL COAGULATION TESTS W01030206 - COAGULATION INHIBITORS/THROMBOPHILIA MARKERS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
Preceding Certificates
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.