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

abbott australasia pty ltd diagnostic division - 48366 - hepatitis c virus total antibody ivd, kit, chemiluminescent assay - the architect anti-hcv assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of antibody to hepatitis c virus (anti-hcv) in human serum and plasma including specimens collected post-mortem (non-heart-beating). the architect anti-hcv assay is intended to be used as an aid in the diagnosis of hepatitis c infection and as a screening test to prevent transmission of hepatitis c virus (hcv) to recipients of blood, blood components, cells, tissue and organs.

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

mp biomedicals australasia pty ltd - 48525 - human t-cell lymphotrophic virus 1 & 2 (htlv1 & htlv2) antibody ivd, kit, immunoblot - the mp diagnostics htlv blot 2.4 is a western blot kit intended as a supplemental antibody assay for characterizing samples found repeatedly reactive by initial htlv-i/ii antibody screening methods. mp diagnostics htlv blot 2.4 is a qualitative enzyme immunoassay for the in vitro detection of antibodies to htlv-i and htlv-ii in human serum or plasma. it is intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using screening procedures like the enzyme-linked immunosorbent assays (elisa).

European Union - English - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - follitropin delta - anovulation - sex hormones and modulators of the genital system, - controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (art) such as an in vitro fertilisation (ivf) or intracytoplasmic sperm injection (icsi) cycle.

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

diasorin australia pty ltd - 48315 - hepatitis b virus surface total antibody ivd, kit, enzyme immunoassay (eia) - a one-step assay based on the sandwich principle. inactivated hbsag is used as solid phase and as conjugate antigen. peroxidase-labelled hbsag binds to hbs-specific antibodies in the sample. these bind to the hbsag bound to the surface of the microtitration plate (antigen sandwich). the enzyme portion of the conjugate results in a blue colour. stopping this reaction causes colour change to yellow. intensity of yellow colour is proportional to the activity of specific antibody in sample. an enzyme immunoassay for the qualitative detection and quantitative determination of specific antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma.

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

ortho-clinical diagnostics australia pty ltd - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - for the in vitro detection of antibodies to hepatits b surface antibody (anti-hbs) in clinical specimens for the in vitro detection of antibodies to hepatits b surface antibody (anti-hbs) in clinical specimens

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

ortho-clinical diagnostics australia pty ltd - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - for the in vitro detection of igm antibody to hepatits b virus core antigen (hbc) in clinical specimens for the in vitro detection of igm antibody to hepatits b virus core antigen (hbc) in clinical specimens

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

beckman coulter australia pty ltd - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - paramagnetic particle, chemiluminescent immunoassay for quantitative determination of antibody levels hep b surface antigen the access hbs ab assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of antibody levels to hepatitis b surface antigen in human serum and plasma using the access immunoassay systems.

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

beckman coulter australia pty ltd - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - paramagnetic-particle, chemiluminescent immunoassay for the detection of igm antibody to core antigen of hepatitis b virus in human serum and plasma using the access immunoassay systems. the access hbc igm assay is a paramagnetic-particle, chemiluminescent immunoassay for the detection of igm antibody to core antigen of hepatitis b virus in human serum and plasma using the access immunoassay systems.

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 - 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.