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.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - microbiology - the advia centaur hbsagii assay is an in vitro immunoassay for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (edta, lithium-heparin, sodium-heparin, or sodium-citrate) using the advia centaur xp systems. the assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infection. the assay may also be used to screen for hepatitis b infection in pregnant women to identify neonates who are at risk of acquiring hepatitis b during the perinatal period.

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

abbott australasia pty ltd diagnostic division - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - this assay consists of two single tests (hbsagnx c1, also referred to as c1 and hbsagnx c2, also referred to as c2) that are both one-step pre-treatment immunoassays for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma using chemiluminescent microparticle immunoassays (cmia) technology with flexible assay protocols, referred to as chemiflex. the hbsag next confirmatory assay is a chemiluminescent microparticle immunoassay (cmia) for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma including specimens collected post mortem (nonheart- beating) up to 24 hours after death by means of specific antibody neutralization on the architect isystem. it is intended to be used for the confirmation of samples found to be repeatedly reactive by hbsag next qualitative.

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

abbott australasia pty ltd diagnostic division - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - this assay consists of 2 single tests (hbsagnx c1, also referred to as c1 and hbsagnx c2, also referred to as c2) that are both one-step pre-treatment immunoassays for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma, using cmia technology. the hbsag next confirmatory assay is a chemiluminescent microparticle immunoassay (cmia) used for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma, including specimens collected post-mortem (non-heartbeating),that have been collected up to 24 hours after death, by means of specific antibody neutralization on the alinity i system.

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

roche diagnostics australia pty limited - 60812 - hepatitis b virus surface antigen neutralization ivd, kit, chemiluminescent immunoassay - the elecsys hbsag confirmatory test is based on the principle of specific antibody neutralization. polyclonal hbsag-specific antibodies bind to the immunodominant epitopes of the hepatitis b surface antigen and thereby block the binding sites for the antibodies used in the assay. immunoassay for in vitro confirmation of the presence of hepatitis b surface antigen in human serum and plasma samples repeatedly reactive when tested with the elecsys hbsag ii assay. this electrochemiluminescence (eclia) assay is intended for use on elecsys and cobas immunoassay analysers.

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - protein (hbsag) - injection - 10 mcg/ml - protein (hbsag) 10 mcg/ml

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - protein (hbsag) - injection - 40 mcg/ml - protein (hbsag) 40 mcg/ml

United States - English - NLM (National Library of Medicine)

a-s medication solutions - hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug in 0.5 ml - engerix-b® is indicated for immunization against infection caused by all known subtypes of hepatitis b virus. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis b-containing vaccine, or to any component of engerix-b, including yeast, is a contraindication to administration of engerix-b [see description (11)]. pregnancy category c animal reproduction studies have not been conducted with engerix-b. it is also not known whether engerix-b can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. engerix-b should be given to a pregnant woman only if clearly needed. it is not known whether engerix-b is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when engerix-b is administered to a nursing woman. safety and effectiveness of engerix-b have been established in all pediatric age-groups. maternally transferred antibodies do not interfere with the active immune response to the vaccine. [see adver

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

abbott australasia pty ltd diagnostic division - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - a chemiluminescent microparticle(cmia)assay for the qualitative detection of hepatitis b surface antigen in human clinical specimens. the architect hbsag qualitative ii assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma including specimens collected up to 24 hours post-mortem (non-heart-beating).

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

abbott australasia pty ltd diagnostic division - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - a chemiluminescent microparticle(cmia) assay for the confirmation of the presence of hbsag in clinical specimens. the architect hbsag qualitative ii confirmatory assay is a chemiluminescent microparticle immunoassay (cmia) for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma including specimens collected up to 24 hours post-mortem.