Australia - English - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - 48304 - hepatitis b virus core total antibody ivd, kit, chemiluminescent immunoassay - the advia centaur hbct2 assay is an antigen-bridging microparticle chemiluminescent immunoassay used for the detection of antibodies to hepatitis b core antigen in human serum or plasma. in vitro diagnostic use in the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbv) in human serum or plasma. this assay can be used as an aid in the diagnosis of individuals (neonates, children, adolescents, and adults) with acute or chronic hepatitis b virus (hbv) infection, and in the determination of the clinical status of hbv-infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. this assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

Singapore - English - HSA (Health Sciences Authority)

all eights (singapore) private limited - hematology - advia retic is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - advia centaur theophylline 2 is for in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the advia centaur and advia centaur xp systems. calibrator 27 is for in vitro diagnostic use in calibrating the advia centaur® theophylline 2 assay.

Australia - English - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - the advia centaur hbc igm assay is an igm capture immunoassay using a 2-step format. antibody-antigen complexes will form if anti-hbc igm is present in the sample. an in vitro diagnostic immunoassay for the qualitative determination of igm response to the core antigen of the hepatitis b virus (hbc igm) in human serum and plasma. this assay is used in combination with other hepatitis b virus (hbv) marker assays in individuals (children, adolescents, and adults) to define the clinical status of known hbv infected patients or it can be combined with other hbv, hav (hepatitis a virus), and hcv (hepatitis c virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis

Australia - English - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - the advia centaur anti-hbs2 assay is a sandwich immunoassay using direct, chemiluminometric technology. the advia centaur anti-hbs2 (ahbs2) assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis b surface antigen in human serum or plasma. the assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection in individuals (neonates, infants, children, adolescents, and adults) prior to or following hbv vaccination or where vaccination status is unknown. assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. a reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

Australia - English - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - 48331 - hepatitis b virus e-antigen ivd, kit, chemiluminescent immunoassay - the advia centaur hbeag assay is an antibody-capture microparticle chemiluminescent immunoassay used to detect human hepatitis b e antigen in human serum and plasma. the advia centaur hbeag assay is an in vitro diagnostic immunoassay for the qualitative determination of the hepatitis b e antigen (hbeag) in human serum and plasma. this assay is used in combination with other hepatitis b virus (hbv) marker assays to define the clinical status of known hbv infected patients. use this assay as an aid in diagnosis of individuals with acute and chronic hepatitis b infection.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical chemistry - the advia 1800 chemistry system is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and stat (interrupt) modes at a throughput rate of 1200 photometric tests per hour and 600 electrolyte tests per hour. the advia 1800 chemistry system is for in vitro diagnostic use.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical chemistry - the advia® 2400 chemistry system is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access and batch modes at a throughput rate of 1800 photometric tests per hour and 600 electrolyte tests per hour. the advia 2400 chemistry system is for in vitro diagnostic use.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - hematology - the advia 360 hematology system is a quantitative, fully-automated, multi-parameter, bench top hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. the advia 360 system provides these hematology parameters: gra%,gra#, hct, hgb, lym%, lym#, mcv, mch, mchc, mid%, mid#, mpv, plt, rbc, wbc. the system can process up to 100 μl of k2 or k3–edta anti-coagulated whole blood from an open or closed sample vial.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - hematology - the advia® 560 hematology system is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories. the system uses the impedance method for measurement of leukocyte (wbc), erythrocyte (rbc), and platelet (plt) concentrations. hemoglobin (hgb) concentration of red blood cells is measured by photometrics. the system provides a 5-part wbc (lym%, mon%, neu%, eos%, bas%) differential measurement using a laser-based optical flow-cytometry technology.the advia 560 hematology system identifies patients with hematologic parameters within and outside of established reference (normal) ranges.