Devices

Device Recall Minutex DDimer

  • Modelo / Serial
    510 K number: K920668  Device listing number: D099358 Lot Numbers: Expiry Date: C040002 10 July 2012 C042002 14 Jan 2012 B218005 05 Jan 2012 B341002 03 May 2012 B144001 30 Sept 2011
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and country of: Canada.
  • Descripción del producto
    Minutex D-Dimer ; Trinity Biotech plc, || Bray, || Co. Wicklow, || Ireland. || Tel: (353) 1 276 9800, || Fax: (353) 1 276 9888, || Web: www.trinitybiotech.com || Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.
  • Manufacturer
    Tcoag Us, Incorporated
  • 1 Event

Fabricante

Tcoag Us, Incorporated
  • Dirección del fabricante
    Tcoag Us, Incorporated, 330 Waterloo Valley Rd, Budd Lake NJ 07828-1395
  • Source
    USFDA