Diagnostica Stago, Inc.

21 devices in the database

  • Model / Serial
    Lot number 02019. Exp. 1/31/2004.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Diagnostica Stago shipped 523 kits to 133 US hospitals, laboratory, and clinics nationwide. There are 6 VA Hospitals.
  • Product Description
    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***.
  • Model / Serial
    Lot 012823 Exp October 2003
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.
  • Product Description
    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.
  • Model / Serial
    All units distributed under Catalog Number 57160.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Units were distributed to clinics and hospitals nationwide.
  • Product Description
    STA-R blood coagulation analyzer. Catalog Number 57160.
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
  • Model / Serial
    Cat. No. 00599 Lot Number 041755 exp. 06/06.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
  • Product Description
    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.
16 more

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    Diagnostica Stago, Inc., 5 Century Drive, Parsippany NJ 07054
  • Source
    USFDA