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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
ARCHITECT Estradiol Reagent. An in vitro diagnostic medical device (IVD) Clinical Chemistry and Clinical Toxicology Devices Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Absorb Bioresorbable Vascular Scaffold (BVS) System Abbott Vascular Division of Abbott Australasia Pty Ltd Australia DHTGA
Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra(Implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices) Cardiovascular Devices St Jude Medical Australia Pty Ltd Australia DHTGA
ARCHITECT Lactic Acid. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Nanostim Leadless Cardiac Pacemaker (LCP) St Jude Medical Australia Pty Ltd Australia DHTGA
Architect Toxo IgM Assay Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Architect Active-B12 Reagent Kit. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
StarClose SE Vascular Closure System (VCS), International Green Sheath Abbott Vascular Division of Abbott Australasia Pty Ltd Australia DHTGA
i-STAT1 Analyser when used with i-STAT Celite Activated Clotting Time (ACT) & Kaolin ACT Cartridges. An in vitro diagnostic medical device (IVD).i-STAT1 Analyser – software version JAMS142E i-STAT Celite ACT Cartridges Abbott Australasia Pty Ltd Point-of-Care Division Australia DHTGA
NC Trek Rx Coronary Dilatation System Cardiovascular Devices Abbott Vascular Division of Abbott Australasia Pty Ltd Australia DHTGA
Absorb Bioresorbable Vascular Scaffold (BVS) System Cardiovascular Devices Abbott Vascular Division of Abbott Australasia Pty Ltd Australia DHTGA
Architect Sex Hormone Binding Globulin (SHBG) reagents. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
ARCHITECT Free T4 Reagent. An in vitro diagnostic medical device (IVD)List Numbers: 7K65-29 (100 Test Kit), 7K65-34 (2000 Test Kit) and 7K65-39 (500 Test Kit)Multiple Lot Numbers (see attached)ARTG Number: 180112 Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
MULTIGENT Creatinine (Enzymatic) assay. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
HeartMate 3 Left Ventricular Assist System (LVAS)Catalogue Number: 106524INT – LVAS KIT, HM 3 St Jude Medical Australia Pty Ltd Australia DHTGA
Alere HIV Combo. An in vitro diagnostic medical device (IVD) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Molecular Division Australia DHTGA
Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices(Implantable cardiac defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices) Manufactured between January 2010 and May 2015 Fortify VRFortify ST VRFortify Assura VRFortify DRFortify ST DRFortify Assura DRUnifyUnify QuadraUnify Quadra MPUnify AssuraQuadra AssuraQuadra Assura MP St Jude Medical Australia Pty Ltd Australia DHTGA
NM Implantable Pulse Generator within the Infinity and Proclaim device families St Jude Medical Australia Pty Ltd Australia DHTGA
Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devices St Jude Medical Australia Pty Ltd Australia DHTGA
i-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW A34. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Point-of-Care Division Australia DHTGA
Architect c4000, c8000, c16000 Cuvette Segment. An in vitro diagnostic medical device (IVD) Clinical Chemistry and Clinical Toxicology Devices Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA