Manufacturers

AdvanDx, Inc.

4 devices in the database

AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit
  • Model / Serial
    Lot Codes Exp date 04310A-U8 2012-08; 03610A-U8 2012-08 ; 02110A-EU 2011-05 ; 02010A-US 2011-05 ; 00410A-US 2011-05 ; 00110A-US 2010-11 ; 07509A-EU 2010-11 ; 07009A-US 2010-11 ; 06409A-US 2010-11 ; 02909A-EU 2010-02 ; 02309A-US 2010-02;
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.
  • Product Description
    AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia || Catalog Number: KT007
AdvanDx EK/P. aeruginosa PNA FISH
  • Model / Serial
    All codes
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including IL, MI, NY, and PA and the country of Denmark
  • Product Description
    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. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods.
Device Recall E.faecalis/OE PNA Fish
  • Model / Serial
    Catalog number KT003
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
  • Product Description
    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 selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media
Device Recall AdvanDx GramNegative QuickFISH BC
  • Model / Serial
    Lot codes US: 04813C, 7413, 08113 exp. 2013-12  Lot codes OUS: 03113A 04213A 04813B
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
  • Product Description
    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