Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD)Thyroid Stimulating Hormone (TSHL)LOCI Free Thyroxine (FT4L)Thyroid Stimulating Hormone (TSH)Cardiac Troponin I (CTNI)Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)Multiple Catalogue Numbers and SMNs (see attached)All Lots (including all future lots until the IFU is updated)ARTG Numbers: 182774, 182220, 180109 & 181687
Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. An in vitro diagnostic medical device (IVD)Assay: Dimension Vista HbA1CCatalogue Number: K3105ASiemens Material Number: 10470481ARTG Number: 181689
Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: K1023Siemens Material Number: 10445160Lot Number: 17171BDARTG Number:181686