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Créditos
Devices
Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test
Modelo / Serial
(Catalog No. 20-005-019) Kit Numbers (US Distribution): 051013019-9, 6288-1, 6547-1, 6420-1, 5478-1, 5802-1, 6190-1, 7360-3, 5452-2, 6499-1, 6414-1, 7183-1, 7511-1, 5225-1, 5225-2, 6495-1, 5760-1, 5779-1, 7259-1, 6783-1, 7435-1 Kit Numbers (Foreign Distribution): 7300-4, 5500-1, 5908-3, 5970-3, 6402-1, 6402-2, 6105-1, 6123-1, 6793-1, 6827-1, 6224-1
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.
Descripción del producto
Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
Manufacturer
Nanosphere, Inc.
1 Event
Retiro De Equipo (Recall) de Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test
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Fabricante
Nanosphere, Inc.
Dirección del fabricante
Nanosphere, Inc., 4088 Commercial Ave, Northbrook IL 60062-1829
Empresa matriz del fabricante (2017)
Luminex Corporation
Source
USFDA
Language
English
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