International Medical Devices Database

Fuente de la data

País

Clasificación del dispositivo

Empresa matriz

Nombre	Clasificación	Fabricante	País	Fuente
Alere INRatio®/Alere INRatio®2	Hematology and Pathology Devices	Alere	Andorra	HA
AQUIOS CL Flow Cytometry System. An in vitro medical device.	Hematology and Pathology Devices	Beckman Coulter 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
HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD)	Hematology and Pathology Devices	Werfen Australia Pty Ltd	Australia	DHTGA
NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Antibody)	Hematology and Pathology Devices	Leica Biosystems Melbourne Pty Ltd	Australia	DHTGA
Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical device (IVD).	Hematology and Pathology Devices	Leica Microsystems 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
Magnetic Silica MagSIL (used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)An in vitro diagnostic medical device (IVD)	Hematology and Pathology Devices	Biomerieux Australia Pty Ltd	Australia	DHTGA
UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System	Hematology and Pathology Devices	Beckman Coulter Australia Pty Ltd	Australia	DHTGA
Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)	Hematology and Pathology Devices	Beckman Coulter Australia Pty Ltd	Australia	DHTGA
VIDAS D-Dimer Exclusion II (An in vitro medical device (IVD))	Hematology and Pathology Devices	Biomerieux Australia Pty Ltd	Australia	DHTGA
UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD)	Hematology and Pathology Devices	Beckman Coulter Australia Pty Ltd	Australia	DHTGA
UniCel DxH 600 & 800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)	Hematology and Pathology Devices	Beckman Coulter Australia Pty Ltd	Australia	DHTGA
Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. An in vitro diagnostic medical device (IVD)	Hematology and Pathology Devices	Zoll Medical Australia Pty Ltd	Australia	DHTGA
Novocastra Liquid Mouse Monoclonal Antibody. An in vitro diagnostic medical device (IVD)	Hematology and Pathology Devices	Leica Biosystems Melbourne Pty Ltd	Australia	DHTGA
Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (An in vitro Diagnostic Medical Device (IVD)	Hematology and Pathology Devices	Leica Biosystems Melbourne Pty Ltd	Australia	DHTGA
ACL Top Family of instruments (haemostasis testing systems). An in vitro diagnostic medical device (IVD).	Hematology and Pathology Devices	Werfen Australia Pty Ltd	Australia	DHTGA
Trade name: OptiView DAB IHC Detection Kit; Ultraview Universal DAB Detection Kit; OptiView Amplification Kit and Hematoxylin II. Technical Name: Immunohistochemistry - Complementary Reagents. ANVISA Registration Number: 10287410832. Hazard Class: I. Affected Model: N / A .. Serial Numbers Affected :. >> Lots Affected Distributed by Roche Diagnóstica Brazil :. OptiView DAB IHC Detection Kit = Lot Y11625. UltraView Universal DAB Detection Kit = Y09284. OptiView Amplification Kit = Lot Y15435. Hematoxylin II = Lot Y13938. >> Lots Affected in Stock in Roche Disgnóstica Brazil :. OptiView DAB IHC Detection Kit = Lots Y11625; Y15571; Y19271. ultraView Universal DAB Detection Kit = Lots Y09284; Y11687; Y15384; Y17984; Y18099. OptiView Amplification Kit = Lot Y15435. Hematoxylin II = Lots Y13938; Y17402; Y17403. NOTE: In the origin (manufacturer) there are other materials and lots affected, but that have not been imported by Brazil so far.	Hematology and Pathology Devices	Roche Diagnóstica Brasil Ltda.; Ventana Medical Systems, Inc.	Brazil	ANVISA
Nuclisens Magnetic Silica Technical Name: Nuclisens EasyMAG Magnetic Silica ANVISA Registration Number: 10158120569 Hazard Class: I Affected Model: Not applicable Serial Numbers Affected: Z017KB1MS / Z017LE1MS / Z017MA1MS and Z017NA1MS	Hematology and Pathology Devices	bioMérieux Brasil Indústria e Comércio de produtos Laboratoriais Ltda.; bioMérieux S.A.	Brazil	ANVISA
Trade name: InRatio 2 Monitoring System Technical Name: Self-Test for Coagulation Parameters ANVISA Registration Number: 10071770848 Hazard Class: III Model Affected: Monitor InRatio2 Pro / Monitor InRatio2	Hematology and Pathology Devices	Alere S.A.; Alere San Diego, Inc.	Brazil	ANVISA
VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM - ANALYZER WITH COMPUTER	Hematology and Pathology Devices	BIO-RAD LABORATORIES (CANADA) LTD.	Canada	HC
HEMOSIL VON WILLEBRAND FACTOR ACTIVITY	Hematology and Pathology Devices	INSTRUMENTATION LABORATORY CO.	Canada	HC
NUCLISENS EASYMAG - MAGNETIC SILICA	Hematology and Pathology Devices	BIOMERIEUX CANADA INC.	Canada	HC
NOVALIS TX LINEAR ACCELERATOR	Hematology and Pathology Devices	VARIAN MEDICAL SYSTEMS INC.	Canada	HC
VARIANT II HEMOGLOBIN TESTING SYSTEM - ANALYZER	Hematology and Pathology Devices	BIO-RAD LABORATORIES (CANADA) LTD.	Canada	HC

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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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