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

beckman coulter australia pty ltd - ct943 - instrument/analyser ivds - instrument/analyser ivds

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

beckman coulter australia pty ltd - ct944 - software ivds - software that has been developed for the purpose of being incorporated into an ivd

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

beckman coulter australia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the access sars-cov-2 igg assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of igg antibodies to sars-cov-2 in serum, serum separator tubes and plasma (edta, citrate and heparin) from individuals with current or prior covid-19 infection. kit, calibrators and qc.

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

beckman coulter australia pty ltd -

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

beckman coulter australia pty ltd - ct890 - immunohaematology calibrator/control ivds - the pk system blood grouping and phenotyping reagents are intended for the determination of blood abo group and rh type and kell phenotypes in blood donors using the beckman coulter pk7300 and/or the beckman coulter pk7400 automated microplate system(s). the pk system blood grouping and phenotyping reagents are intended for the determination of blood abo group and rh type and kell phenotypes in blood donors using the beckman coulter pk7300 and/or the beckman coulter pk7400 automated microplate system(s).

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

beckman coulter australia pty ltd - ct886 - reagent red blood cell ivds - the pk system blood grouping and phenotyping reagents are intended for the determination of blood abo group and rh type and kell phenotypes in blood donors using the beckman coulter pk7300 and/or the beckman coulter pk7400 automated microplate system(s). the pk system blood grouping and phenotyping reagents are intended for the determination of blood abo group and rh type and kell phenotypes in blood donors using the beckman coulter pk7300 and/or the beckman coulter pk7400 automated microplate system(s).

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

beckman coulter australia pty ltd - ct887 - immunohaematology blood grouping antisera ivds - the pk system blood grouping and phenotyping reagents are intended for the determination of blood abo group and rh type and kell phenotypes in blood donors using the beckman coulter pk7300 and/or the beckman coulter pk7400 automated microplate system(s). the pk system blood grouping and phenotyping reagents are intended for the determination of blood abo group and rh type and kell phenotypes in blood donors using the beckman coulter pk7300 and/or the beckman coulter pk7400 automated microplate system(s).

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

beckman coulter australia pty ltd - ct1270 - immunohaematology-related ivds - ivds that are intended to be used alone or in combination with other ivds to perform various immunohaematology-related tests on the beckman coulter pk7300 and pk7400 automated microplate systems with the pk system blood grouping and phenotyping reagents.

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

beckman coulter australia pty ltd - ct907 - histology and cytology ancillary ivds - ivds that are intended to be used alone or in combination with other ivds to perform various histology and cytology-related tests and procedures.

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

beckman coulter australia pty ltd - ct1056 - immunohistology cell marker ivds - ivds that are intended to be used in histology and cytology to provide information about the presence and localisation of specific proteins and antigens