Advandx Inc — FDA Profile

Summary

Number	Class	Product	Date
Z-2138-2014	Class II	AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFI	July 4, 2014
Z-0619-2014	Class III	AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriaca	December 11, 2013
Z-0112-2013	Class II	AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherich	September 14, 2012
Z-0116-2013	Class II	AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escheric	September 14, 2012

K-Number	Device	Date
K140619	MECA XPRESSFISH	October 10, 2014
K123418	GRAM-NEGATIVE QUICKFISH BC	July 21, 2013
K121991	ENTEROCOCCUS QUICKFISH BC	January 7, 2013
K113371	STAPHYLOCOCCUS QUICKFISH BC	April 3, 2012
K101558	GNR TRAFFIC LIGHT PNA FISH	December 16, 2010
K093024	YEAST TRAFFIC LIGHT PNA FISH	July 15, 2010
K092784	C. ALBICANS/C. GLABRATA PNA FISH	March 12, 2010
K092655	C. ALBICANS PNA FISH	January 19, 2010
K092236	E.COLI/P. AERUGINOSA PNA FISH	December 16, 2009
K092166	S. AUREUS/CNS PNA FISH, MODEL KT005	November 23, 2009
K092393	EK/P. AERUGINOSA PNA FISH	September 1, 2009
K091827	S. AUREUS PNA FISH	August 18, 2009
K083074	AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT	July 24, 2009
K082068	E. COLI PNA FISH	June 25, 2009
K082612	GBS PNA FISH	May 5, 2009
K081433	EK/P. AERUGINOSA PNA FISH	March 26, 2009
K081309	E.COLI/P. AERUGINOSA PNA FISH	December 19, 2008
K080719	YEAST TRAFFIC LIGHT PNA FISH	September 12, 2008
K063127	ENTEROCOCCUS FAECALIS PNA FISH	December 22, 2006
K062461	C. ALBICANS PNA FISH	October 25, 2006