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

roche diagnostics australia pty limited - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay "eclia" intended for use on the cobas e immunoassay analyzers. immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma, for diagnostic use and testing of blood donations.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - elecsys hbsag ii is an immunoassay for the in vitro qualitative determination of hepatitis b surface antigen (hbsag) in human serum and plasma. the electrochemiluminescence immunoassay "eclia" is intended for use on cobas e immunoassay analyzers. the performance has been established for diagnostic use and for screening of blood donations and for use of cadaveric blood specimens (plasma only).

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - elecsys toxo igm is an immunoassay for the in vitro qualitative determination of igm antibodies to toxoplasma gondii in human serum or plasma. the electrochemiluminescence immunoassay "eclia" is intended for use on the elecsys and cobas e immunoassay analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - clinical chemistry - elecsys ck-mb stat is an immunoassay for the in vitro quantitative determination of the mb isoenzyme of creatine kinase in human serum and plasma. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - elecsys ig e ii is an immunoassay for the in vitro quantitative determination of immunoglobulin e in human serum and plasma on the cobas e analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - elecsys total psa immunoassay is a quantitative in vitro diagnostic test for total (free + complexed) prostate-specific antigen (tpsa) in human serum and plasma, is indicated for the measurement of total psa in conjunction with digital rectal examination as an aid in the detection of prostate cancer in men aged 50 years or older. prostate biopsy is required for diagnosis of prostate cancer. this test is further indicated for serial measurement of tpsa to aid in the management of cancer patients. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - elecsys anti‑sars‑cov‑2 is an immunoassay for the in vitro qualitative detection of antibodies (including igg) to severe acute respiratory syndrome coronavirus 2 (sars‑cov‑2) in human serum and plasma. the test is intended as an aid in the determination of the immune reaction to sars‑cov‑2. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - elecsys hcv duo is an immunoassay for the in vitro qualitative detection of hepatitis c virus (hcv) core antigen (hcv ag) and antibodies to hcv (anti‑hcv) in human serum and plasma. the test, in conjunction with other laboratory results and clinical information, may be used to aid in the diagnosis of and the screening for hcv infection. the test can also be used as a screening test to prevent transmission of hcv to recipients of blood, blood components, cells, tissue, and organs. the subresults (hcv ag and anti‑hcv) are intended as an aid in the selection of the confirmatory testing algorithm for reactive samples. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers. the performance has been established for diagnostic use and for screening of blood donations and for use of cadaveric blood specimens (serum only).’

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for the in vitro quantitative determination of degradation products of type i collagen in human serum and plasma as an aid in assessing bone resorption. the test may be used as an aid in monitoring antiresorptive therapies in osteoporotic patients. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Singapura - Inggris - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - immunoassay for the in vitro qualitative determination of igm antibodies to the hepatitis a virus in human serum and plasma. the assay is used as an aid to detect an acute or recently acquired hepatitis a virus infection. the electrochemiluminescence immunoassay “eclia” is intended for use on elecsys and cobas e immunoassay analyzers.