Devices

E. coli/P. aeruginosa PNA FISH

  • Model / Serial
    Lot Numbers: 01812A-US, 03412A-US and 00512A-EU  Exp Date: 12-2013
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.
  • Product Description
    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.
  • Manufacturer
    Advandx Inc
  • 1 Event

Manufacturer

Advandx Inc
  • Manufacturer Address
    Advandx Inc, 400 Tradecenter, Ste 6990, Woburn MA 01801
  • Manufacturer Parent Company (2017)
    Advandx, Inc.
  • Source
    USFDA

One device with a similar name

Learn more about the data here

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
  • Manufacturer
    AdvanDx, Inc.