Address:Radiova 1,Prague Praha, Hlavni Mesto,CZ
Device Description : The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitr The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
Device Class : 2
Duns Number: 270264732
Premarket Exempt : No
Prescription Use : Yes
Device Description : CD38-SuperNova v428
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CD19-SuperNova v428
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CD25-SuperNova v428
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CD99-APC
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CD99-ECD
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : ANTI-IL-4-PE
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CD20-SuperNova v605
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CD25-SuperNova v605
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CD200-SuperNova v786
Device Class : 1
Duns Number: 270264732
Premarket Exempt : Yes
Prescription Use : Yes