Abbott Diagnostic International, Ltd.

14 dispositifs dans la base de données

  • Modèle / numéro de série
    Lot # 44161Q100 Exp. Date: 08/23/2007,  Lot # 46295Q100 Exp. Date: 8/23/2007,  Lot # 48239Q100 Exp. Date: 01/04/2008, and Lot# 50238Q100 Exp. Date: 05/20/2008
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
  • Description du dispositif
    XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number 9506-10
  • Modèle / numéro de série
    Lot # 42442Q100 Exp. Date: 07/17/2007,  Lot # 44791Q100 Exp. Date: 10/09/2007,  Lot # 46753Q100 Exp. Date: 12/10/2007,  Lot # 48107Q100 Exp. Date: 10/09/2007,  Lot # 50236Q100 Exp. Date: 04/21/2008, and  Lot # 51591Q100 Exp. Date: 04/21/2008
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
  • Description du dispositif
    XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).-Product List Number-9506-01
  • Modèle / numéro de série
    Lot # 43273Q100 Exp. Date: 06/23/2007 and  Lot # 47028Q100 Exp. Date; 10/14/2007
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
  • Description du dispositif
    AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing quinidine prepared in human serum to yield the different concentration ranges-Product List Number 7A73-10
  • Modèle / numéro de série
    Lot # 44794Q100 Exp. Date: 08/09/2007 and  Lot # 47093Q100 Exp. Date: 10/10/2007
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
  • Description du dispositif
    AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01
  • Modèle / numéro de série
    LIST # 01L82-10 Lots # 48253Q101 Exp Date 09/26/2007, 48253Q100Exp Date 06/19/2007, 45556Q100 Exp Date 03/14/2007, 45557Q100 Exp Date 01/01/2007, 44595Q100 Exp Date 02/28/2007, and 42586Q100 Exp Date 01/01/2007
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Puerto Rico
  • Description du dispositif
    ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.
9 en plus

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  • Adresse du fabricant
    Abbott Diagnostic International, Ltd., Carr # 2 Km 58.0, Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA
  • Adresse du fabricant
    Abbott Diagnostic International, Ltd., Carr 2 Km 58.0, Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA