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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Panbio Dengue IgM Capture ELISA, An in vitro diagnostic medical device (IVD) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
ARCHITECT STAT High Sensitive Troponin-I Calibrators and Controls Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Alere DDS2 Test Kits (Drug screening test system). An in vitro diagnostic medical device (IVD) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Riata and Riata ST Silicone Endocardial Defibrillation Leads Cardiovascular Devices St Jude Medical Australia Pty Ltd Australia DHTGA
Phosphorus Reagent. An in vitro diagnostic medical device (IVD). (Used for the quantitation of phosphorus in human serum, plasma or urine)Used for the quantitation of phosphorus in human serum, plasma or urine. Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Panbio Barmah Forest Virus IgM ELISA. An in vitro diagnostic medical device (IVD). Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Panbio Barmah Forest Virus IgM ELISA (An in vitro diagnostic medical device (IVD)) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral anticoagulation therapy) (An in vitro diagnostic medical device (IVD)) Abbott Australasia Pty Ltd (Point-of-Care Division) Australia DHTGA
AxSYM Valproic Acid Reagent (An in vitro diagnostic medical device IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters). An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd T/A Abbott Diabetes Care Australia DHTGA
HT Connect Peripheral Guide Wires (used for percutaneous transluminal Agioplasty (PTA) in peripheral arteries) Cardiovascular Devices Abbott Vascular Division of Abbott Australasia Pty Ltd Australia DHTGA
St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0 Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families St Jude Medical Australia Pty Ltd Australia DHTGA
ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
FreeStyle Papillon Mini Blood Glucose Monitoring System Abbott Australasia Pty Ltd T/A Abbott Diabetes Care Australia DHTGA
VerifyNow IIb/IIIa 25 Test and VerifyNow IIb/IIIa 10 Test (An in vitro Diagnostic Medical Device (IVD)) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Alere Triage BNP Test for Beckman Coulter (intended to measure B-type Natriuretic Peptide levels) Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Lipase Reagent (diagnostic good for the quantitation of lipase in human serum or plasma) Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
Alere INRatio2 PT/INR Heparin Insensitive Test Strips Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
AGA Medical Amplatzer Septal Occluder Amplatzer Septal Occluder, 28mm St Jude Medical Australia Pty Ltd Australia DHTGA
Alere Triage BNP Calibrator for Beckman Coulter Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
m24sp Instrument System (sample extraction system). An in vitro diagnostic medical device (IVD) Abbott Australasia Pty Ltd Molecular Division Australia DHTGA
5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD) Clinical Chemistry and Clinical Toxicology Devices 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
Clinical Chemistry ICT Serum Calibrator. An in vitro diagnostic medical device (IVD) Clinical Chemistry and Clinical Toxicology Devices Abbott Australasia Pty Ltd Diagnostic Division Australia DHTGA
St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs) Cardiovascular Devices St Jude Medical Australia Pty Ltd Australia DHTGA