Austrália - inglês - Department of Health (Therapeutic Goods Administration)

revvity pty ltd - ct936 - specimen receptacle ivds - this is intended to be used for the collection, containment, preservation and transport of clinical specimens for analysis or investigation.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

revvity pty ltd - ct903 - inborn/inherited genetic disorder ivds - inborn/inherited genetic disorder ivds

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

revvity pty ltd - ct944 - software ivds - software for the collection, input, storage, retrieval, interpretation or reporting of digital data or other information.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

revvity pty ltd - ct910 - interpretive software ivds - prenatal screening risk assessment software for prenatal conditions.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

revvity pty ltd - ct826 - constitutional chromosomal disorder ivds - ct826 constitutional chromosomal disorder ivds ivds that are intended to be used in genetic testing for diagnosing, monitoring or predicting the presence of chromosomal abnormalities of a constitutional nature (ie. present in all cells of the body).

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

revvity pty ltd - ct889 - multiple clinical chemistry constituent ivds - the assay is intended for the quantitative measurement of the activity of the enzymes acid-?-glucocerebrosidase (abg), acid-sphingomyelinase (asm), acid ? glucosidase (gaa), ? galactocerebrosidase (galc), ?-galactosidase a (gla) and ?-l-iduronidase (idua) in dried blood spots (dbs).

Cingapura - inglês - HSA (Health Sciences Authority)

revvity singapore pte. ltd. - immunology - it is intended for the quantitative determination of the free ß subunit of human chorionic gonadotropin (free hcgß) in maternal serum using the 6000 delfia® xpress clinical random access screening platform. biochemical markers for screening for risk of down’s syndrome are used together with risk calculation software, e.g. wallac lifecycle with elipse screening engine. this kit is intended for use in one of the combinations described below: in the first trimester of pregnancy: free hcg ß + papp-a free hcg ß + papp-a + nt (nuchal trasnslucency) in the second trimester of pregnancy: free hcg ß + hafp free hcg ß + hafp + ue3.

Cingapura - inglês - HSA (Health Sciences Authority)

revvity singapore pte. ltd. - immunology - this kit is intended for the quantitative determination of human 17α-oh-progesterone kit in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (cah).

Cingapura - inglês - HSA (Health Sciences Authority)

revvity singapore pte. ltd. - obstetrics & gynaecology - the intended use of lifecycle for prenatal lifecycle screening software is screening software is prenatal screening of prenatal conditions. the lifecycle for prenatal screening performs risk assessment for t21 condition.

Cingapura - inglês - HSA (Health Sciences Authority)

revvity singapore pte. ltd. - immunology - sero maternal health control - early is a lyophilized human control serum manufactured under strict quality control standards. it is intended for use as an assayed quality control serum to monitor precision and trueness of laboratory measurement procedures for the analytes described in the package insert in quantitative manual, semi-automated and automated immunoassays. three levels of controls are available to allow performance monitoring within the clinical range. this product is not intended for use as a calibrator.