Basic Information
- Number
- HX 1070846-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- June 17, 2024
- Expiry Date
- January 31, 2028
- Revision
- Rev. 2
- Manufacturer
- Thermo Fisher Scientific Oy
Certificate Lifecycle
Scopes
7 scopes covering 2 risk classes
Quality Procedure Scope
CLINICAL CHEMISTRY IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers W01010103 - ALANINE AMINO-TRANSFERASE W01010105 - ALKALINE PHOSPHATASE – TOTAL W01010110 - ASPARTATE AMINO-TRANSFERASE W01010111 - CHOLINESTERASE W01010113 - CREATINE KINASE - TOTAL W01010116 - GAMMA GLUTAMYLTRANSFERASE W01010119 - LACTATE DEHYDROGENASE L (LDH - L-->P) W01010123 - LIPASE W01010201 - ALBUMIN (CC) W01010203 - BILIRUBIN W01010204 - UREA/BLOOD UREA NITROGEN W01010205 - CHOLESTEROL W01010207 - CREATININE W01010215 - HIGH DENSITY LIPOPROTEIN CHOLESTEROL W01010216 - IRON (CC) W01010221 - LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL W01010230 - TOTAL PROTEIN W01010231 - TRIGLYCERIDES W01010232 - URIC ACID W01010302 - BICARBONATE W01010303 - CALCIUM W01010306 - MAGNESIUM W01010307 - PHOSPHATE INORGANIC / PHOSPHORUS W01010502 – SPECIFIC CONTROLS (CC) W01010503 - CALIBRATORS AND STANDARDS (CC) W01010606 - ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC W01010701 - ELECTROLYTE ELECTRODES W01010703 - REFERENCE MATERIAL AND BUFFERS (ELECTROLYTES) W01019099 - CLINICAL CHEMISTRY REAGENTS – OTHER
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status. W01020101 - IMMUNOGLOBULINS (EXCEPT IGE W01021104 - ANTISTREPTOLYSIN O (QUANTITATIVE) W01021109 - C-REACTIVE PROTEIN W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 – STANDARDS AND CALIBRATORS
Quality Procedure Scope
IMMUNOCHEMISTRY IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers W01020102 - COMPLEMENT COMPONENTS W01020103 - TRANSPORT PROTEINS W01020104 - LIPOPROTEINS W01020701 - ANEMIA W01021110 - RHEUMATOID FACTORS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
CLINICAL CHEMISTRY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010213 - GLUCOSE W01010214 – GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
Quality Procedure Scope
CLINICAL CHEMISTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010107 - AMYLASE - TOTAL W01010114 - CREATINE KINASE - MB ACTIVITY (CC) W01010230 - TOTAL PROTEIN W01010501 - MULTICOMPONENT CONTROLS (CLINICAL CHEMISTRY) W01010502 - SPECIFIC CONTROLS (CLINICAL CHEMISTRY) W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)
Quality Procedure Scope
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030205 – FIBRINOLYSIS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021109 - C-REACTIVE PROTEIN W01021520 - CONTROLS - IMMUNOCHEMISTRY
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.