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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
m24sp Instrument System (sample extraction system). An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Molecular Division Australia DHTGA
Panbio Q Fever IgM ELISA (An in vitro diagnostic medical device (IVD)) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Abbott RealTime Assay Application CD-ROM Abbott Australasia Pty Ltd Molecular Division Australia DHTGA
Eon/Eon C/ Eon Mini/ Prodigy Neurostimulation Systems and Octrode/ Quattrode Percutaneous Leads and Accessories St Jude Medical Australia Pty Ltd Australia DHTGA
Alere Determine HIV-1/2 Ag/Ab Combo (an in vitro diagnostic medical device) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Eon Mini Implantable Pulse Generator (IPG) Model 65-3788 and Eon Mini Charging System Model 3721 Neurological Devices St Jude Medical Australia Pty Ltd Australia DHTGA
Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Captia Malaria EIA (An in vitro Diagnostic Medical Device (IVD)) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Alere Actim Partus. An in vitro diagnostic medical device (IVD). Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Sensei X Robotic Catheter System Cardiovascular Devices St Jude Medical Australia Pty Ltd Australia DHTGA
RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150 St Jude Medical Australia Pty Ltd Australia DHTGA
ARCHITECT Anti-HBc II Reagent Kit. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Captia Malaria EIA Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Sekisui Diagnostics Acetaminophen Reagent. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Eon Wall Charger Model 3701 and Eon Portable Charger Neurological Devices St Jude Medical Australia Pty Ltd Australia DHTGA
i-STAT PT/INR Cartridges(prothrombin time test) Abbott Australasia Pty Ltd Point-of-Care Division Australia DHTGA
ARCHITECT B12 Reagent kit7K61-35 Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System. An in vitro diagnostic medical device (IVD). Abbott Australasia Pty Ltd T/A Abbott Diabetes Care Australia DHTGA
Brio Charging System Model 6721 (used with Deep Brain Stimulator, Brio IPG Model 65-6788) St Jude Medical Australia Pty Ltd Australia DHTGA
MULTIGENT Ammonia Ultra Reagent. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Optisure Dual Coil Defibrillation Leads(Lead, defibrillator/pacemaker, implantable Cardiovascular Devices St Jude Medical Australia Pty Ltd Australia DHTGA
Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold with bioresorbable polymeric drug coating mounted on a balloon dilatation catheter) Abbott Vascular Division of Abbott Australasia Pty Ltd Australia DHTGA
Acetaminophen (Paracetamol) Reagent (used with L3K Assay in conjunction with the Architect cSystem Analyser). An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CDS02ST) and the Steerable Guide Catheter (Part number # SGC01ST)(Used for reconstruction of the insufficient mitral valve through tissue approximation) Abbott Vascular Division of Abbott Australasia Pty Ltd Australia DHTGA
i-STAT troponin I Assay Cartridges (cTnl). An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Point-of-Care Division Australia DHTGA