VIDAS DDimer Exclusion II

  • Model / Serial
    Reference 304551-01 - Lots 1001625210, Exp. date 8/8/20123; 1001715580, Exp. date 9/26/2013; 1001711530, Exp. date 9/11/2013; 1001789540, Exp. date 10/29/2013; 1001932680, Exp. date 12/12/2013
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY
  • Product Description
    VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Manufacturer Parent Company (2017)
  • Source
    USFDA