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

roche diagnostics australia pty limited - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay "eclia" intended for use on the cobas e immunoassay analyzers. immunoassay for the in vitro qualitative determination of hepatitis b surface antigen (hbsag) in human serum and plasma, for diagnostic use, screening of blood donations.

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

diasorin australia pty ltd - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - liaison? xl murex hbsag quant assay uses chemiluminescence immunoassay (clia) technology for the quantitative determination of hepatitis b surface antigen (hbsag) in human serum or plasma samples. for the quantitative determination of hepatitis b surface antigen (hbsag) in human serum and plasma samples, including specimens collected up to 24 hours post-mortem (non-heart beating).

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

roche diagnostics australia pty limited - 42000 - hepatitis b virus surface antigen ivd, control - a ready to use control serum based on human serum both in the negative and positive concentration range. for quality control of the elecsys hbsag ii and elecsys hbsag ii auto confirm immunoassays on the elecsys and cobas e immunoassay analysers.

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

ortho-clinical diagnostics australia pty ltd - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - for in vitro detection of hepatitis b surface antigen (hbsag) in clinical specimens for in vitro detection of hepatitis b surface antigen (hbsag) 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.

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

merck sharp & dohme llc - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 5 ug in 0.5 ml - recombivax hb® [hepatitis b vaccine, recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. recombivax hb is approved for use in individuals of all ages. recombivax hb dialysis formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. do not administer recombivax hb to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis b-containing vaccine or to any component of recombivax hb, including yeast [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. there are no adequate and well-controlled studies designed to evaluate recombivax hb in pregnant women. available post-approval data do not suggest an in

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

a-s medication solutions - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 10 ug in 1 ml - recombivax hb® [hepatitis b vaccine, recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. recombivax hb is approved for use in individuals of all ages. recombivax hb dialysis formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. do not administer recombivax hb to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis b-containing vaccine or to any component of recombivax hb, including yeast [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. there are no adequate and well-controlled studies designed to evaluate recombivax hb in pregnant women. available post-approval data do not suggest an in

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

dynavax technologies corporation - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 20 ug in 0.5 ml - heplisav-b is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. heplisav-b is approved for use in adults 18 years of age and older. do not administer heplisav-b to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis b vaccine or to any component of heplisav-b, including yeast [see description (11)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to heplisav-b during pregnancy. women who receive heplisav-b during pregnancy are encouraged to contact 1-844-443-7734. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in clinically recognized pregnancies in the us general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20%. there are no clinical studies of heplisav-b in pregnant women. available human data on heplisav- b administered to pregnant wo

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

roche diagnostics australia pty limited - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay ?eclia? is intended for use on the cobas e immunoassay analyzers for the in vitro qualitative determination of hepatitis b surface antigen (hbsag). immunoassay for the in vitro qualitative determination of hepatitis b surface antigen (hbsag) in human serum and plasma, for diagnostic use and screening of blood donations.

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 is used to confirm the presence of hepatitis b surface antigen (hbsag) in human serum and plasma, using chemiluminescent microparticle immunoassay (cmia) technology. this assay consists of two single tests that are both one-step pretreatment immunoassays. the alinity s hbsag confirmatory assay is used to confirm the presence of hepatitis b surface antigen (hbsag) in human serum and plasma, including specimens collected up to 24 hours postmortem (non-heartbeating), by means of specific antibody neutralization on the alinity s system. the assay is intended to be used for the confirmation of samples found to be repeatedly reactive by the alinity s hbsag assay