AdvanDx, Inc.
FDA Regulatory Profile
AdvanDx, Inc. appears in FDA public data with 4 recalls, 21 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2138-2014, Class II) was initiated on July 4, 2014. Its most recent 510(k) clearance was granted on October 10, 2014.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 21
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| 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-0116-2013 | Class II | AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escheric | September 14, 2012 |
| Z-0112-2013 | Class II | AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherich | September 14, 2012 |
Recent 510(k) Clearances
| 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 |