Basic Information
- Number
- HX 1333941-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- March 21, 2023
- Expiry Date
- March 20, 2028
- Revision
- 1
- Manufacturer
- B·R·A·H·M·S GmbH
Certificate Lifecycle
Scopes
6 scopes covering 2 risk classes
Quality Procedure Scope
IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020410 - THYROID STIMULATING HORMONE
Quality Procedure Scope
IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01020501 - FERTILITY FUNCTION HORMONES / PROTEINS W01020409 - THYROID BINDING GLOBULIN W01020401 - FREE TRIIODOTHYRONINE W01020402 - FREE THYROXINE
Quality Procedure Scope
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020390 - OTHER TUMOUR MARKERS W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01020603 - BONE AND MINERAL METABOLISM ASSAYS
Quality Procedure Scope
IVR 506: Other devices intended to be used to determine markers of infections/immune status W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01021399 - CARDIAC MARKERS – OTHER
Quality Procedure Scope
IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021301 - BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01021399 - CARDIAC MARKERS – OTHER W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER
Quality Procedure Scope
IVR 0601: Devices intended to be used for screening/confirmation of specific disorders/impairments W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
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.