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

abbott australasia pty ltd t/a abbott diabetes care - 59016 - subcutaneous glucose sensor - the sensor measures and stores glucose readings when worn on the body. the sensor has a small, flexible tip that is inserted just under the skin. when used with the libre pro reader, the health care professional is able to review a patient's ambulatory glucose profile over the last 14 days. the freestyle libre pro flash glucose monitoring system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. the system is intended for use by health care professionals.

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

abbott australasia pty ltd t/a abbott diabetes care - 44611 - invasive interstitial-fluid glucose monitoring system - glucose meter reader to assist in the determination of interstitial-fluid glucose levels in human specimens.

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

abbott australasia pty ltd t/a abbott diabetes care - 44081 - information system software, application program, home healthcare - to be used with glucose monitoring systems.

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

abbott australasia pty ltd t/a abbott diabetes care - 37243 - lancet, automatic - non invasive, non-measuring lancing device and test cap.

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

abbott australasia pty ltd t/a abbott diabetes care - 37466 - lancet, manual, single use - the purpose of the device when used with a manual lancing device is to obtain a drop of capillary blood.

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

abbott australasia pty ltd t/a abbott diabetes care - ct910 - interpretive software ivds - software used with an ivd analyser

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

abbott australasia pty ltd t/a abbott diabetes care - 59016 - subcutaneous glucose sensor - the sensor measures and stores glucose readings when worn on your body. the sensor has a small, flexible tip that is inserted just under the skin and can be worn for up to 14 days when it needs to be replaced. the sensor is a component of the freestyle libre 2 flash glucose monitoring system, a real time, continuous glucose monitoring (cgm) device indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with insulin dependent diabetes mellitus. the indication for children (age 4-17) is limited to those who are supervised by a caregiver who is at least 18 years of age.

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

abbott australasia pty ltd t/a abbott diabetes care - 58884 - self-care monitoring web-based application software - software used in conjunction with a system for the determination and recording of interstitial fluid substrate in humans

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

abbott australasia pty ltd diagnostic division - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - a chemiluminescent microparticle immunoassay for the qualitative determination of anti-hbc in clinical specimens. a chemiluminescent microparticle immunoassay for the qualitative determination of anti-hbc in clinical specimens

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

abbott australasia pty ltd diagnostic division - 48304 - hepatitis b virus core total antibody ivd, kit, chemiluminescent immunoassay - a chemiluminescent microparticle assay for the qualitative determination of anti-hbc in clinical specimens. the architect anti-hbc ii assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of antibody to hepatitis b core antigen (anti-hbc) in human serum and plasma, including specimens collected post-mortem (non-heart beating) on the architect analyser. performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heart beating) that have been collected up to 24 hours after death.