Basic Information
- Number
- HX 1170693-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- October 17, 2024
- Expiry Date
- October 16, 2029
- Revision
- Rev. 0
- Manufacturer
- DRG Instruments GmbH
Certificate Lifecycle
Scopes
5 scopes covering 2 risk classes
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01020501 – FERTILITY FUNCTION HORMONES/PROTEINS
Quality Procedure Scope
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020602 - RENAL METABOLISM ASSAYS W01020701 - ANEMIA
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0402: Devices intended to be used to predict genetic disease/disorder risk and prognosis W01020502 - PREGNANCY TESTING HORMONES / PROTEINS
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0605: Devices intended to be used for monitoring of levels of medicinal products, substances or biological components W01020803 - ANTIBIOTIC TDM / ANTIVIRUS TDM
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.