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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K132843
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Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC... 2 08/10/2020 Luminex Corporation
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result... 2 08/08/2014 Nanosphere, Inc.
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021 2 07/02/2021 Luminex Corporation
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. ... 2 08/14/2014 Nanosphere, Inc.
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitativ... 2 09/30/2014 Nanosphere, Inc.
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 2 05/17/2022 Luminex Corporation
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-re... 2 09/23/2014 Nanosphere, Inc.
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