Device Dossier
Clinical chemistry-specific protein IVDs
Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 3, sponsor Getz Healthcare). ARTG…
- GMDN category: CT974 - Clinical chemistry-specific protein IVDs
Intended purpose
The IVD CAPSULE PSP is a single use, rapid in vitro diagnostic test for the quantitative measurement of pancreatic stone protein (PSP) in human K3-EDTA anticoagulated venous and capillary whole blood as an aid in the early recognition of sepsis. The IVD CAPSULE PSP is to be used with the abioSCOPE 2.0 in vitro diagnostic test system.