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

genesis biotech pty ltd - ct833 - clinical chemistry substrate ivds - self-testing blood glucose and multi-functional monitoring systems, which may include measurement of glucose, ?-ketone, lactate, total cholesterol, triglycerides, and uric acid for the monitoring and management of blood levels of one or more reportable parameters, not intended to be used for diagnosis or screening of diseases. the devices may also be used for testing by health professionals, including use of fingertip capillary blood (all parameters), arterial blood samples (glucose only), venous blood samples (glucose and ketone) and neonatal blood samples (glucose only)

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

nipro australia pty ltd - 62537 - home-use blood glucose monitoring system ivd - this system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and by health care professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. it is intended to be used for the quantitative measurement of glucose (sugar) and beta-ketone with capillary blood from finger- tip and alternate sites (glucose only) as well as venous and arterial blood (professional use only).

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

roche diagnostics australia pty limited - ct833 - clinical chemistry substrate ivds - ivds that are intended to be used for the quantitative determination of clinical chemistry substrates in a clinical specimen

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

roche diagnostics australia pty limited - ct943 - instrument/analyser ivds - instruments that are intended to be used as an ivd for the purposes of processing, examining and/or providing information about a clinical specimen

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

nipro australia pty ltd - ct833 - clinical chemistry substrate ivds - the blood glucose test strips or ketone test strips are intended to be used together with the meters by the patient at home or by healthcare professionals for quantitative measurement of glucose (sugar) with capillary blood from the fingertip or alternate site and venous and arterial blood (professional use only) and beta-hydroxybutyrate (ketone) in fresh whole blood samples from the finger. it should not be used for the diagnosis of diabetes, or screening for diabetes mellitus.

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

nipro australia pty ltd - ct943 - instrument/analyser ivds - the meter is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and by health care professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. it is intended to be used with the specified test strips for the quantitative measurement of glucose (sugar) with capillary blood from the finger- tip, alternate sites and venous and arterial blood (professional use only), and to measure beta-hydroxybutyrate (ketone) in fresh whole blood samples from the finger.

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

genesis biotech pty ltd - 17148 - oximeter, pulse - fingertip pulse oximeter is intended to be used for non-invasive spot check measurement of oxygen saturation of arterial hemoglobin (spo2) and pulse rate, on patients at rest.

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

genesis biotech pty ltd - 17887 - thermometer, infrared, ear - ear thermometer used to measure the infrared heat generated by the eardrum and its surrounding tissue and is intended for the intermittent measurement and monitoring of human body temperature from the ear canal. the device is intended for use by people of all ages for home and professional use.

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

acra regulatory services pty ltd - 57812 - radiology dicom image processing application software - briefcase is a radiological computer aided triage and notification software indicated for use in the analysis of radiological images. the device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging and communication of suspected positive findings the following indications: 1.intracranial hemorrhage (ich) triage, non-enhanced head ct. 2.cervical spine fracture (csf) triage, non-enhanced cervical spine ct, bone kernel only. 3.pulmonary embolism (pe) triage, ctpa. 4.vessel occlusion (vo) triage, head cta (vo on m1). 5.intra-abdominal free gas (ifg) triage, abdomen ct. 6.incidental pulmonary embolism (ipe) triage, chest ct. 7.rib fracture (ribfx) triage, chest ct (with or without contrast). 8.brain aneurism (ba) triage, head cta. 9.pulmonary nodules (pn) qc, chest and abdomen ct (with and without contrast). 10.pneumothorax (ptx) triage, frontal chest x-ray. 11. vertically malpositioned endotracheal tube in relation to the carina (ett) 12. aortic dissection (ad) 13. vertebral compression fractures (vcfx) briefcase uses an artificial intelligence algorithm to analyse images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. the user is presented with notifications for cases with suspected findings. notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. the device does not alter the original medical image and is not intended to be used as a diagnostic device. the results of briefcase are intended to be used in conjunction with other patient information and based on the user?s professional judgment, to assist with triage/prioritization of medical images. notified clinicians are responsible for viewing full images per the standard of care.

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

device technologies australia pty ltd - 13116 - cover, thermometer, electronic probe - a device used to provide a physical barrier between the patient and the electronic probe of a thermometer during medical examination.