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

helena laboratories australia pty ltd - ct879 - haematology calibrator/control ivds - ivds that are intended to be used in testing to establish known points of reference and/or verify the performance of haematological assays.

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

helena laboratories australia pty ltd - ct877 - coagulation factor ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of individual clotting factors within the coagulation cascade.

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

helena laboratories australia pty ltd - ct874 - platelet factor ivds - ivds that are intended to be used in testing to provide information about platelet factor components or platelet functionality.

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

helena laboratories australia pty ltd - ct871 - general coagulation ivds - ivds that are intended to be used in testing to provide information about the general coagulation of blood and the time taken for a clinical blood specimen to clot following initiation of the intrinsic and/or extrinsic coagulation pathways.

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

helena laboratories australia pty ltd - ct833 - clinical chemistry substrate ivds - intended for the qualitative and/or quantitative determination of clinical chemistry substrates in a clinical specimen.

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

helena laboratories australia pty ltd - ct827 - clinical chemistry enzyme ivds - intended for the qualitative and/or quantitative determination of clinical chemistry enzymes in a clinical specimen.

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

helena laboratories australia pty ltd - ct943 - instrument/analyser ivds - manual, semi-automated or automated equipment or apparatus that are intended to be used as an ivd for the purposes of of processing, examining and/or providing information about a clinical specimen.

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

helena laboratories australia pty ltd - ct287 - clinical chemistry ivds - qualitative screening of faeces for blood(faecal occult blood) using a guaiac slide. for professional use only.

Hviterussland - russisk - Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

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