Diagnostica Stago, Inc.

21 dispositifs dans la base de données

  • Modèle / numéro de série
    Lot number 02019. Exp. 1/31/2004.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Diagnostica Stago shipped 523 kits to 133 US hospitals, laboratory, and clinics nationwide. There are 6 VA Hospitals.
  • Description du dispositif
    STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive, Parsippany, NJ 07054, Lot 02019***.
  • Modèle / numéro de série
    Lot 012823 Exp October 2003
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.
  • Description du dispositif
    FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. || The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. || Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.
  • Modèle / numéro de série
    All units distributed under Catalog Number 57160.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Units were distributed to clinics and hospitals nationwide.
  • Description du dispositif
    STA-R blood coagulation analyzer. Catalog Number 57160.
  • Modèle / numéro de série
    Lot 050947D --exp. April 2007; Lot 051527A -- exp. June 2007; Lot 051527B -- exp. June 2007; Lot 051527C -- exp. June 2007; Lot 051527D -- exp. June 2007.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
  • Modèle / numéro de série
    Cat. No. 00599 Lot Number 041755 exp. 06/06.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
  • Description du dispositif
    PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
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  • Adresse du fabricant
    Diagnostica Stago, Inc., 5 Century Drive, Parsippany NJ 07054
  • Source
    USFDA