Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
SIEMENS HEALTHCARE PTE. LTD.
Class C IVD
Siemens Healthcare Diagnostics Inc
Immunology
The ADVIA Centaur BRAHMS PCT (Procalcitonin) assay is intended for the quantitative measurement of procalcitonin in human serum and plasma using the ADVIA Centaur, ADVIA Centaur CP and ADVIA Centaur XP systems. This assay is not intended for use on any other system. The ADVIA Centaur BRAHMS PCT assay is indicated, in conjunction with other laboratory findings and clinical assessments, as an aid 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.
Models: ADVIA® Centaur XP System - 073-A011-02, ADVIA® Centaur BRAHMS PCT (Procalcitonin) assay - 10378883, BRAHMS PCT quality control material - 10378884, ADVIA Centaur Wash 1 - 01137199 (112351), ADVIA Centaur Wash 1 - 3773025, ADVIA Centaur Multi-Diluent 1 - 07907174 (110313), ADVIA Centaur Multi-Diluent 1 - 07293184 (110312), ADVIA Centaur CP Test Definition Version 1.0.AD - 10819293, ADVIA Centaur Acid and Base reagent - 00497043 (10313526), ADVIA Centaur XP System Software V 5.3.0.2 - 11220449, ADVIA Centaur XP System Software V 7.3.0.4 - 11222242, ADVIA Centaur CP System - 086-A002-01, 09662772 (10309710), ADVIA Centaur® XP Immunoassay System - 078-A011-R03
2012-12-17