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

beckman coulter australia pty ltd - 61225 - treponema pallidum immunoglobulin g (igg)/igm antibody ivd, kit, agglutination - beckman coulter pk tp system is intended for the qualitative screening of blood donors for the detection of treponema pallidum igg and igm antibodies in human serum or edta plasma using the beckman coulter pk7300, automated microplate system. the test is based on the principle of agglutination and pattern recognition. the beckman coulter pk tp system utilizes fixed chicken erythrocytes sensitized with components of the pathogenic t. pallidum

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

beckman coulter australia pty ltd - ct878 - haematology full blood count ivds - ivds that are intended to be used for the qualitative and/or quantitative haematological determination of measured and/or calculated whole blood cell parameters.

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

beckman coulter australia pty ltd - ct1236 - clinical chemistry biological screening ivds - ivds that are intended to be used for the qualitative and/or quantitative screening of urine, faeces and other biological specimens for chemical, cellular or other components using a dipstick or other broadly indicative method.

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

beckman coulter australia pty ltd - ct899 - tissue typing-related ivds - ivds that are intended to be used alone or in combination with other ivds to perform various tissue typing-related tests and procedures

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

beckman coulter australia pty ltd - ct945 - general laboratoryware ivds - general reagents, laboratory products, consumables, biological stains, that are intended to be used specifically as an ivd in the testing of clinical specimens within any discipline of a pathology laboratory.

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

beckman coulter australia pty ltd - ct887 - immunohaematology blood grouping antisera ivds - the test is based on the principles of agglutination and pattern recognition. when red blood cells with antigens react with bromelin , agglutination occurs with an antibody indicates the presence of the specific antigen. the pk72 /7300 analyzers will read the microplate and make a determination. the beckman coulter 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 pk7200 and or the beckman coulter pk7300 auto microplate system

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

beckman coulter australia pty ltd - ct1270 - immunohaematology-related ivds - the beckman coulter? pk? system bromelin is intended for use as a diluent in the preparation of red blood cells for the determination of abo blood grouping and rh type and kell phenotyping on the beckman coulter pk7200 and pk7300 automated microplate systems with the beckman coulter pk system blood grouping and phenotyping reagents.

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

beckman coulter australia pty ltd - ct890 - immunohaematology calibrator/control ivds - the beckman coulter control is devoid of antibody activity and should be used in parallel testing the beckman coulter control is devoid of antibody activity and should be used in parallel testing with the beckman coulter pk system blood grouping and phenotyping reagents to differentiate between specific and non-specific agglutination.

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

beckman coulter australia pty ltd - ct886 - reagent red blood cell ivds - the test is based on hemagglutination principles. reagent red blood cells with specific antigens agglutinate in the presence of corresponding antibodies contained in donor plasma. the absence of agglutination indicates the absence of the specific antibody in the donor plasma. the analyzers read the settling patterns and make a determination. the beckman coulter? pk? system reagent red blood cels (a1 and b) are intended for the determination of the reverse or plasma group on the beckman coulter pk7200 and pk7300 automated analyzers.

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

beckman coulter australia pty ltd - ct869 - clinical chemistry autoimmune ivds - the rf latex calibrator is a liquid human serum based matrix calibrator intended to be used with the rf latex reagent osr61105 for the quantitative determination of rheumatoid factor on beckman coulter analysers. clinical chemistry autoimmune ivds