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

beckman coulter australia pty ltd - 48304 - hepatitis b virus core total antibody ivd, kit, chemiluminescent immunoassay - qualitative immunoassay integrated to the access immunoassay systems, for the detection of antibodies directed against hepatitis b core antigen in human serum or plasma the access hbc ab assay is a qualitative immunoassay integrated to the access immunoassay systems, for the detection of antibodies directed against hepatitis b core antigen in human serum or plasma.

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.

Singapore - English - HSA (Health Sciences Authority)

beckman coulter singapore pte. ltd. - immunology - the access hbc ab assay is a qualitative immunoassay integrated to the access immunoassay systems, for the detection of antibodies directed against hepatitis b core antigen in human serum or plasma

Singapore - English - HSA (Health Sciences Authority)

beckman coulter singapore pte. ltd. - immunology - 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.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for the in vitro qualitative determination of igg and igm antibodies to the hepatitis b core antigen in human serum and plasma. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers. the performance has been established for use of cadaveric blood specimens (plasma only).

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - microbiology - for in vitro diagnostic use with the immulite 2000 systems analyzers — for the qualitative detection of total antibodies against hepatitis b core antigen (hbcag) in human serum or plasma (heparinized, sodium citrate or edta), as an aid in the determination of a prior immune status to the hepatitis b virus.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for the in vitro qualitative determination of igm antibodies to the hepatitis b core antigen in human serum and plasma. the electrochemiluminescence immunoassay “eclia” is intended for use on elecsys and cobas e immunoassay analyzers.

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

roche diagnostics australia pty limited - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - ??capture test principle immunoassay: total duration of assay: 18 minutes. results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. immunoassay and dedicated quality control for the in vitro qualitative determination of igm antibodies to the hepatitis b core antigen in human serum and plasma. this electrochemiluminescence (eclia) assay is intended for use on elecsys and cobas immunoassay analysers.

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

roche diagnostics australia pty limited - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody 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 igm antibodies to the hepatitis b core antigen. immunoassay for the in vitro qualitative determination of igm antibodies to the hepatitis b core antigen in human serum and plasma, for diagnostic use and testing of blood donations.

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

roche diagnostics australia pty limited - 48304 - hepatitis b virus core total antibody ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay "eclia" intended for use on cobas e immunoassay analyzers immunoassay for the in vitro qualitative determination of igg and igm antibodies to the hepatitis b core antigen in human serum and plasma, for diagnostic use and for screening of blood donations.