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Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test
Model / 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
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.
Product Description
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
Recall of Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test
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Manufacturer
Nanosphere, Inc.
Manufacturer Address
Nanosphere, Inc., 4088 Commercial Ave, Northbrook IL 60062-1829
Manufacturer Parent Company (2017)
Luminex Corporation
Source
USFDA
Language
English
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