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Advandx Inc

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. T recall (Z-2138-2014)Advandx Inc2014-08-01
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enteroba recall (Z-0619-2014)AdvanDx, Inc.2014-01-02
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for recall (Z-0112-2013)Advandx Inc2012-10-22
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for recall (Z-0116-2013)Advandx Inc2012-10-22
AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. col recall (Z-0491-2011)AdvanDx, Inc.2010-12-01
AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. recall (Z-0490-2011)AdvanDx, Inc.2010-11-29
E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multic recall (Z-2315-2010)AdvanDx, Inc.2010-08-31

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