No specific devices are listed for this certificate.
Characteristics
Sterile
No
Human tissues
No
Animal tissues
No
In vitro diagnostics
—
Initial registration
No
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
Intended medical purpose
—
SPP applicable
—
Conditions applicable
No
MOS outside EUDAMED
No
QMS/MOS type
Others
History
Status changes
Supplemented
Supersedes
HX 1060415-1Quality management systemIssuedJan 12, 2024 → Jan 11, 2029
Scope coverage
IVDR Class C1
1 scope
IMMUNOCHEMISTRY (IMMUNOLOGY)
IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer
W01020301 - CANCER ANTIGENS
IVR 0607 Devices intended to be used for detection of
pregnancy or fertility testing
W01021520 - IMMUNOCHEMISTRY
CONTROLS/STANDARDS/CALIBRATORS