Company ยท US
Advandx, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2014. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JSS | Kit, Identification, Enterobacteriaceae | 12 |
| NXX | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus | 5 |
| OAH | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis | 5 |
| NZS | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast | 3 |
| JXB | Kit, Identification, Yeast | 2 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 10, 2014 | K140619 | MECA XPRESSFISH Advandx, Inc. | MYI |
| Jul 21, 2013 | K123418 | GRAM-NEGATIVE QUICKFISH BC Advandx, Inc. | JSS |
| Jan 7, 2013 | K121991 | ENTEROCOCCUS QUICKFISH BC Advandx, Inc. | OAH |
| Apr 3, 2012 | K113371 | STAPHYLOCOCCUS QUICKFISH BC Advandx, Inc. | NXX |
| Dec 16, 2010 | K101558 | GNR TRAFFIC LIGHT PNA FISH Advandx, Inc. | JSS |
| Jul 15, 2010 | K093024 | YEAST TRAFFIC LIGHT PNA FISH Advandx, Inc. | NZS |
| Mar 12, 2010 | K092784 | C. ALBICANS/C. GLABRATA PNA FISH Advandx, Inc. | NZS |
| Jan 19, 2010 | K092655 | C. ALBICANS PNA FISH Advandx, Inc. | NZS |
| Dec 16, 2009 | K092236 | E.COLI/P. AERUGINOSA PNA FISH Advandx, Inc. | JSS |
| Nov 23, 2009 | K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 Advandx, Inc. | NXX |
| Sep 1, 2009 | K092393 | EK/P. AERUGINOSA PNA FISH Advandx, Inc. | JSS |
| Aug 18, 2009 | K091827 | S. AUREUS PNA FISH Advandx, Inc. | NXX |
| Jul 24, 2009 | K083074 | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT Advandx, Inc. | OAH |
| Jun 25, 2009 | K082068 | E. COLI PNA FISH Advandx, Inc. | JSS |
| May 5, 2009 | K082612 | GBS PNA FISH Advandx, Inc. | OAH |
| Mar 26, 2009 | K081433 | EK/P. AERUGINOSA PNA FISH Advandx, Inc. | JSS |
| Dec 19, 2008 | K081309 | E.COLI/P. AERUGINOSA PNA FISH Advandx, Inc. | JSS |
| Sep 12, 2008 | K080719 | YEAST TRAFFIC LIGHT PNA FISH Advandx, Inc. | JXB |
| Dec 22, 2006 | K063127 | ENTEROCOCCUS FAECALIS PNA FISH Advandx, Inc. | OAH |
| Oct 25, 2006 | K062461 | C. ALBICANS PNA FISH Advandx, Inc. | JXB |
| May 8, 2006 | K060099 | S. AUREUS PNA FISH Advandx, Inc. | NXX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2014 | Advandx Inc AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test
Ca Terminated |
NXX | K113371 |
| Jan 2, 2014 | AdvanDx, Inc. AdvanDx Gram-Negative QuickFISH BC.
In-Vitro Diagnostic for the identification of Enterobacteriacae
Catalog Number: QFGNRBC1-25
Gram-Negative QuickFISH BC provides rapid identification of Escherichi Terminated |
JSS | K123418 |
| Oct 22, 2012 | Advandx Inc AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa
Catalog number: KT011.
GNR Traf Terminated |
JSS | None listed |
| Oct 22, 2012 | Advandx Inc AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa
Catalog Number : KT007
Usage: E. coli/P. aeruginosa PNA FISH i Terminated |
JSS | None listed |
| Dec 1, 2010 | AdvanDx, Inc. AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic)
Catalog number: KT008
EK/P. aerugin Terminated |
JSS | K092393 |
| Nov 29, 2010 | AdvanDx, Inc. AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia
Catalog Number: KT007 Terminated |
JSS | K092236 |
| Aug 31, 2010 | AdvanDx, Inc. E.faecalis/OE PNA FISH
Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and s Terminated |
OAH | K083074 |