Devices

Device Recall Wako Autokit Lp(a) Calibrator

  • Modèle / numéro de série
    Lot No.: DJ427, Exp 08-31-12
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product had been sold to 2 customers in the US.
  • Description du dispositif
    Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics || 1600 Bellwood Road Richmond, VA 23237*** || Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
  • Manufacturer
    Wako Chemicals USA, Inc.
  • 1 Event

Fabricant

Wako Chemicals USA, Inc.
  • Adresse du fabricant
    Wako Chemicals USA, Inc., 1600 Bellwood Rd, Richmond VA 23237-1326
  • Société-mère du fabricant (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA