Basic Information
- Number
- HX 1290554-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- November 26, 2024
- Expiry Date
- September 15, 2026
- Revision
- Rev. 13
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
Certificate Lifecycle
Scopes
26 scopes covering 3 risk classes
Quality Procedure Scope
CLINICAL CHEMISTRY IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01021520 - CONTROLS – IMMUNOCHEMISTRY
Quality Procedure Scope
IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01020801 - CARDIOVASCULAR TDM W01020802 - CENTRAL NERVOUS SYSTEMS TDM W01020803 - ANTIBIOTIC TDM / ANTIVIRUS TDM W01020804 - ANTI-ASTHMA TDM W01020806 - IMMUNOSUPPRESSANT TDM W01020902 - TOXICOLOGY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01029003 - BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
Quality Procedure Scope
IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020501 - FERTILITY FUNCTION HORMONES / PROTEINS W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020190 - OTHER SPECIFIC PROTEINS W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
INFECTIOUS DISEASES IVR 0501: Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents W01050401 - RUBELLA VIRUS W01050402 - CYTOMEGALOVIRUS W01050403 - HERPES SIMPLEX VIRUS W01050501 - TOXOPLASMA W01050808 - CONTROLS - INFECT. IMMUNOLOGY
Quality Procedure Scope
INFECTIOUS DISEASES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050202 - HEPATITIS B VIRUS W01050808 - CONTROLS - INFECT. IMMUNOLOGY
Quality Procedure Scope
IVR 0502: Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration including sexually transmitted agents
Quality Procedure Scope
CLINICAL CHEMISTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010207 - CREATININE W01010213 - GLUCOSE W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) W01010701 - ELECTROLYTE ELECTRODES
Quality Procedure Scope
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020101 - IMMUNOGLOBULINS (EXCEPT IGE) W01020102 - COMPLEMENT COMPONENTS W01020103 - TRANSPORT PROTEINS W01020104 - LIPOPROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01020601 - DIABETES ASSAYS (HORMONES) W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01020702 - VITAMINES W01021112 - ANTI-CYCLIC CITRULLINATED PEPTIDE W01021307 - HOMOCYSTEINE W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
Quality Procedure Scope
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W02010102 - LIMITED PANEL CHEMISTRY ANALYSERS
Quality Procedure Scope
IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010103 - ALANINE AMINO-TRANSFERASE W01010110 - ASPARTATE AMINO-TRANSFERASE W01010111 - CHOLINESTERASE W01010210 - FRUCTOSAMINE W01010216 - IRON (CC) W01010217 - IRON BINDING CAPACITY - TOTAL (CC) W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)
Quality Procedure Scope
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010105 - ALKALINE PHOSPHATASE - TOTAL W01010119 - LACTATE DEHYDROGENASE L ( LDH - L --> P ) W01010123 - LIPASE W01010201 - ALBUMIN (CC) W01010203 - BILIRUBIN W01010204 - UREA/BLOOD UREA NITROGEN W01010218 - LACTATE W01010230 - TOTAL PROTEIN W01010232 - URIC ACID W01010301 - AMMONIA W01010302 - BICARBONATE W01010303 - CALCIUM W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) W01010602 - URINE TESTING (CC) - RT & POC
Quality Procedure Scope
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030101 - REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER W01030105 - HAEMATOLOGY CONTROLS AND CALIBRATORS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W02020101 - AUTOMATED 5 PART DIFFERENTIAL HEMATOLOGY ANALYSERS
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01020103 - TRANSPORT PROTEINS W01020190 - OTHER SPECIFIC PROTEINS W01020401 - FREE TRIIODOTHYRONINE W01020402 - FREE THYROXINE W01020405 - TRIIODOTHYRONINE W01020406 - T- UPTAKE W01020407 - THYROXINE W01020410 - THYROID STIMULATING HORMONE W01020601 - DIABETES ASSAYS (HORMONES) W01020603 - BONE AND MINERAL METABOLISM ASSAYS W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01020701 - ANEMIA W01020702 - VITAMINES W01021003 - THYROID-AUTO-IMMUNE DISEASE W01021110 - RHEUMATOID FACTORS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01029003 - BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
Quality Procedure Scope
IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01020901 - DRUGS OF ABUSE W01020902 - TOXICOLOGY
Quality Procedure Scope
INFECTIOUS DISEASES IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050201 - HEPATITIS A VIRUS W01050808 - CONTROLS - INFECT. IMMUNOLOGY
Quality Procedure Scope
Products of class B for near-patient testing: CLINICAL CHEMISTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010602 - URINE TESTING (CC) - RT & POC
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01021603 - FERTILITY / PREGNANCY RT & POC
Quality Procedure Scope
IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021520 - CONTROLS - IMMUNOCHEMISTRY
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01021104 - ANTI-STREPTOLYSIN O (QUANTITATIVE)
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS W01020303 - ONCOPROTEINS W01020390 - OTHER TUMOUR MARKERS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01029003 - BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) W01020603 - BONE AND MINERAL METABOLISM ASSAYS
Quality Procedure Scope
IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01021301 - BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) W01021304 - MYOGLOBIN W01021306 - TROPONIN I/T W01021311 - CREATINE KINASE - MB MASS (IC) W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01010214 - GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
Quality Procedure Scope
IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01030608 - CYTOKINES CALIBRATORS/CONTROLS W01030609 - INTERLEUKIN 6 (IL-6)
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01020190 - OTHER SPECIFIC PROTEINS W01021520 - CONTROLS – IMMUNOCHEMISTRY
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0401: Devices intended to be used in screening/confirmation of congenital/inherited disorders W01020502 - PREGNANCY TESTING HORMONES / PROTEINS
Quality Procedure Scope
CLINICAL CHEMISTRY IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01010305 - LITHIUM
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.