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

revvity pty ltd - ct936 - specimen receptacle ivds - revvitytm 226 sample collection device is intended to be used as a medium to collect and transport blood specimen spots to a laboratory. the sample is to be collected by qualified laboratory professionals.

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

revvity pty ltd - ct943 - instrument/analyser ivds - manual, semi-automated or automated equipment intended by the manufacturer to be used as an in vitro diagnostic medical device (ivd) for the purposes of processing, examining and/or providing information about a clinical specimen.

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

revvity pty ltd - ct943 - instrument/analyser ivds - manual, semi-automated or automated equipment or apparatus that are intended by the manufacturer to be used as an in vitro diagnostic medical device (ivd) for the purposes of processing, examining and/or providing information about a clinical specimen.

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

revvity pty ltd - ct946 - general laboratory reagent and consumables ivds - ivds that are general laboratory reagents, products or consumables, that are intended to be used specifically as an ivd in the testing of specimens within a clinical laboratory.

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

revvity pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to sars-cov-2 virus.

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

revvity pty ltd - ct702 - multiple-viruses ivds - the pkamp respiratory sars-cov-2 rt-pcr panel assay is a real-time rt-pcr multiplexed test intended for the simultaneous qualitative detection and differentiation of rna from sars-cov-2, influenza a viruses, influenza b viruses and respiratory syncytial virus (rsv) or simultaneous qualitative detection and differentiation of rna from sars-cov-2, influenza a viruses and influenza b viruses or detection of sars-cov-2 rna only in upper respiratory specimens (nasopharyngeal, oropharyngeal and nasal swabs) collected from individuals suspected of respiratory viral infection consistent with covid-19 by a healthcare provider.

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

revvity pty ltd - ct791 - mycobacteria ivds - the t-spot.tb test is an in vitro diagnostic test for the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens and is intended for use as an aid in the diagnosis of tuberculosis (tb) infection. the t-spot.tb test is a simplified enzyme-linked immunospot (elispot) method which enumerates individual tb-specific activated effector t cells.

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

revvity pty ltd - ct943 - instrument/analyser ivds - the intended purpose of the wizard2 instrument is to detect and count gamma radiation emitted from solid and liquid samples, that were prepared through the addition of a radioactive reagent for downstream clinical applications. the instrument is intended to be used by trained laboratory personnel. wizard2? automatic gamma counters are designed for counting performance with all types of samples and for every gamma counting application. unique well-type detectors and sample changer system, advanced robotics, and highly effective lead shielding result in high counting efficiency, low background and minimal crosstalk. an operating system with touch screen for easy and fast instrument operation of routine tasks makes wizard2 very user-friendly. the instrument supports in vitro diagnostic use in clinical laboratories and is optionally available as 21cfr part 11 compatible to fulfill pharmaceutical industry requirements. there are two basic wizard2 counter models, 2470 wizard2 automatic gamma counter and 2480 wizard2 automatic gamma counter. additionally, 2470 wizard2 is available in a number of different configurations.

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

revvity pty ltd - ct943 - instrument/analyser ivds - the janus g3 automated workstation is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. liquid transfers can be performed in a multi-tipped mode from any combination of laboratory containers including 384- and 1536-well formats for complete assay automation. the janus g3 system is controlled by winprep? - a flexible, powerful, and intuitive software application - running on a windows-compatible computer.

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

revvity pty ltd - ct827 - clinical chemistry enzyme ivds - intended to be used for the qualitative and/or quantitative determination of clinical chemistry enzymes in a clinical specimen.