Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - microbiology - the advia centaur anti-hbe assay is an in vitro diagnostic immunoassay for the qualitative determination of antibody response to the e antigen of the hepatitis b virus (hbv) in human serum and plasma using the advia centaur and advia centaur xp systems. use this assay in combination with other hepatitis b virus (hbv) marker assays to define the clinical status of known hbv infected patients. the anti-hbe control is for monitoring the performance of the anti-hbe assay on the advia centaur® systems. the performance of the anti-hbe quality control material has not been established with any other anti-hbe assay.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - it is for in vitro diagnostic use in the quantitative determination of b-type natriuretic peptide (bnp) in human plasma using the advia centaur and advia centaur xp systems. this assay is indicated for the measurement of plasma bnp as an aid in the diagnosis and assessment of the severity of heart failure. in patients with acute coronary syndromes (acs), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. this assay is not intended for use on any other system.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - the advia centaur® brahms procalcitonin (pct) assay is for in vitro diagnostic use in the quantitative determination of pct in human serum and plasma (edta, lithium heparin and sodium heparin)using the advia centaur xp, advia centaur xpt and advia centaur cp systems.it is intended for use,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 icu admission for progression to severe sepsis and septic shock. •assessing the cumulative 28 day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the icu or when obtained in the emergency department or other medical wards prior to icu admission, using percent change in pct level over time. •decision-making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections. •decision-making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical toxicology - for in vitro diagnostic use in the quantitative determination of carbamazepine in serum or plasma using the advia centaur xp systems.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - for in vitro diagnostic use in the quantitative measurement of carcinoembryonic antigen (cea) in serum and plasma (edta and lithium heparin) to aid in the management of cancer patients in whom changing concentrations of cea are observed using the advia centaur xp systems.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - this in vitro diagnostic assay is intended to quantitatively measure complexed prostate-specific antigen (cpsa) in human serum using the advia centaur® cp and xp systems. this assay is indicated for the measurement of serum complexed psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. biopsy of the prostate is required for the diagnosis of prostate cancer. this assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - the advia centaur® dheas assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (dheas) in human serum and plasma using the advia centaur and advia centaur xp.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical toxicology - for in vitro diagnostic use in the quantitative determination of digoxin in serum and plasma (edta and lithium heparin) using the advia centaur® cp system and advia centaur xp system. measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical toxicology - for in vitro diagnostic use in the quantitative determination of gentamicin in serum or plasma using the advia centaur cp, advia centaur xp and advia centaur xpt systems.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical toxicology - it is for in vitro diagnostic use in the quantitative determination of phenobarbital in serum or plasma using the advia centaur xp systems.