Basic Information
- Number
- HX 1782924-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- September 13, 2024
- Expiry Date
- June 29, 2026
- Revision
- Rev. 4
- Manufacturer
- QIAGEN GmbH
Certificate Lifecycle
Scopes
5 scopes covering 2 risk classes
Quality Procedure Scope
GENETIC TESTING IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
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 W01050107 - Mycobacteria Genus + Species W01050705 - MULTIPLE PANELS FOR INFECTIONS - VARIOUS
Quality Procedure Scope
SAMPLES COLLECTION DEVICES IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W05010101 - Venous or Arterious Blood Collection Devices
Quality Procedure Scope
NUCLEIC ACID TESTING INSTRUMENTS IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours IVR 0403 Other devices intended to be used for human genetic testing W02050192 – NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
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 W01050705 - MULTIPLE PANELS FOR INFECTIONS - VARIOUS
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.