Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - for in vitro diagnostic use in the quantitative determination of alpha-fetoprotein (afp) in the following: i) human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neural tube defects (ntds) when used in conjunction with ultrasonography and amniography testing, ii) human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the advia centaur, advia centaur xp and advia centaur cp systems.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - the advia centaur® anti-ccp igg (accp) assay is for in vitro diagnostic use in the semi-quantitative determination of the igg class of autoantibodies specific to cyclic citrullinated peptide (ccp) in human serum (serum and serum separator tube) or plasma (potassium edta and lithium heparin) using the advia centaur xp and advia centaur xpt systems. detection of anti-ccp antibodies is used as an aid in the diagnosis of rheumatoid arthritis (ra) and should be used in conjunction with other clinical information. autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments.

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. - immunology - for in vitro diagnostic use in the quantitative, serial determination of ca 125 in human serum and plasma (edta and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the advia centaur® xp systems

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - the advia centaur® ca 15-3 assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen ca 15-3 in human serum and plasma (edta and lithium heparin) using the advia centaur® xp and advia centaur® xpt systems. when used in conjunction with other clinical and diagnostic procedures, serial testing with the advia centaur ca 15-3 assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated stage ii, with greater than two positive lymph nodes, or stage iii breast cancer patients. this assay is not intended for use on any other system.

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 - for in vitro diagnostic use in the quantitative determination of ck-mb in serum or heparinized plasma using the advia cp and xp systems.