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

thermo fisher scientific australia pty ltd - ct945 - general laboratoryware ivds - laboratory reagents, products or consumables, that are intended to be used specifically as an ivd in the testing of specimens within a clinical laboratory.

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

thermo fisher scientific australia pty ltd - ct943 - instrument/analyser ivds - instruments / analysers used as an in vitro diagnostic medical device (ivd) for the purposes of processing, examining and/or providing information about a clinical specimen.

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

lmt surgical pty ltd - 45199 - stereotactic surgery system, multi-purpose - intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

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

r-biopharm pty ltd - ct355 - viral infectious disease ivds - ivds to be used in testing to provide information about infection with or exposure to norovirus, adenovirus, rotavirus or astrovirus.

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

abbott australasia pty ltd diagnostic division - ct184 - clinical chemistry toxicology/drug detection ivds - for the detection of drugs or toxic substances in clinical specimens

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

abbott australasia pty ltd diagnostic division - ct860 - clinical chemistry therapeutic drug monitoring ivds - for the determination of therapeutic drugs in human clinical specimens

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

thermo fisher scientific australia pty ltd - ct910 - interpretive software ivds - b?r?a?h?m?s fast screen pre i plus software for non-invasive risk assessment of fetal trisomy 21, 18 and 13 in the 1st, of trisomy 21, 18 and fetal neural tube defect in the 2nd trimester of pregnancy as well as for 1st trimester risk assessment for developing pre-eclampsia

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

r-biopharm pty ltd - ct860 - clinical chemistry therapeutic drug monitoring ivds - intended to be used in monitoring of therapeutic drug levels in a clinical specimen

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

r-biopharm pty ltd - ct749 - herpes simplex virus (hsv) (human herpesvirus 1 & 2) ivds - intended to provide information about infection with or exposure to herpes simplex virus 1 and/or herpes simplex virus 2

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

axis medical & rehabilitation - 47790 - electromechanical orthopaedic extracorporeal shock wave therapy system - a device that generates a high energy sound wave for the treatment of muscular and some orthopaedic disorders to alleviate pain and increase functionality and mobility.