Advandx, Inc.
Advandx, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2014, with 4 FDA device recalls on record.
Top product codes for Advandx, Inc.
FDA recalls by Advandx, Inc.
- Z-2138-2014 — 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 Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
- Z-0619-2014 — 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 Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
- Z-0116-2013 — 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 is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
- Z-0112-2013 — 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 Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Advandx, Inc.
- K140619 — MECA XPRESSFISH
- K123418 — GRAM-NEGATIVE QUICKFISH BC
- K121991 — ENTEROCOCCUS QUICKFISH BC
- K113371 — STAPHYLOCOCCUS QUICKFISH BC
- K101558 — GNR TRAFFIC LIGHT PNA FISH
- K093024 — YEAST TRAFFIC LIGHT PNA FISH
- K092784 — C. ALBICANS/C. GLABRATA PNA FISH
- K092655 — C. ALBICANS PNA FISH
- K092236 — E.COLI/P. AERUGINOSA PNA FISH
- K092166 — S. AUREUS/CNS PNA FISH, MODEL KT005
- K092393 — EK/P. AERUGINOSA PNA FISH
- K091827 — S. AUREUS PNA FISH
- K083074 — AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
- K082068 — E. COLI PNA FISH
- K082612 — GBS PNA FISH
- K081433 — EK/P. AERUGINOSA PNA FISH
- K081309 — E.COLI/P. AERUGINOSA PNA FISH
- K080719 — YEAST TRAFFIC LIGHT PNA FISH
- K063127 — ENTEROCOCCUS FAECALIS PNA FISH
- K062461 — C. ALBICANS PNA FISH
- K060099 — S. AUREUS PNA FISH
Data sourced from openFDA. This site is unofficial and independent of the FDA.