Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - the advia centaur® testosterone ii (tstii) assay is for in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the advia centaur, advia centaur xp, and advia centaur xpt systems. for professional use. measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - immunology - the advia centaur vitamin d total (vitd) assay is for in vitro diagnostic use in the quantitative determination of total 25 (oh) vitamin d in human serum and plasma (edta, lithium-heparin, sodium-heparin) using the advia centaur xp, and advia centaur xpt systems. the advia centaur vitd assay is intended as an aid in the determination of vitamin d sufficiency.

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

siemens healthcare pty ltd - 48360 - hepatitis c virus immunoglobulin g (igg) antibody ivd, kit, chemiluminescent immunoassay - advia centaur hcv is an indirect two wash sandwich immunoassay used for the detection of igg antibody to hepatitis c virus (hcv) in human serum or plasma. an in vitro diagnostic immunoassay for the qualitative determination of igg antibodies to hepatitis c virus (hcv) in clinical specimens. this ivd may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis c infection.

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

siemens healthcare pty ltd - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - the advia centaur chiv assay is a two-wash antigen/antibody sandwich immunoassay using direct chemiluminometric technology an in vitro diagnostic immunoassay intended to be used in testing clinical specimens for the detection of human immunodeficiency virus (hiv) p24 antigen and antibodies to human immunodeficiency virus type 1 (hiv-1), including group "o", and/or type 2 (hiv-2), to aid in the diagnosis of hiv infection.

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 hbc total assay is an antigen bridging microparticle chemiluminometric immunoassay used for the detection of antibodies to hepatitis b core antigen in human serum or plasma. an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbc total) in clinical specimens.

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 antibody capture microparticle chemiluminometric immunoassay used for the detection of igm antibody to hepatitis b core antigen in human serum or plasma. an in vitro diagnostic immunoassay for the qualitative determination of igm response to the core antigen of the hepatitis b virus (hbc igm) in clinical specimens.

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

siemens healthcare pty ltd - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - the advia centaur hbsag confirmatory assay uses the principle of specific antibody neutralization to confirm the presence of hbsag in a sample that is repeatedly reactive for hbsag. an in vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis b surface antigen (hbsag) in clinical specimens.

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

siemens healthcare pty ltd - 42000 - hepatitis b virus surface antigen ivd, control - quality control material for the advia centaur hbsag, hbsagii and hbsag confirmatory assays using direct chemiluminometric technology. for monitoring the performance of the advia centaur hbsag, hbsagii and hbsag confirmatory assays.

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

siemens healthcare pty ltd - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - the advia centaur hbsagii assay is a magnetic particle chemiluminometric immunoassay used to measure the amount of hepatitis b surface antigen in human serum and plasma. an in vitro diagnostic immunoassay for the qualitative detection of hepatitis b surface antigen (hbsag) in clinical specimens. the assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infection.

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 an antibody-capture microparticle direct chemiluminometric immunoassay used to measure the amount of antibody to hepatitis b surface antigen in human serum and plasma. an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis b surface antigen in clinical specimens.