PLAC Test Reagent Kit

  • Model / Serial
    10-0112, 10-0113, 10-0115 | 078011, 088061, 098091, 109011
    119021, 129031, 139051, 139051A
  • Product Description
    IVD: Phospholipase A2 kit
  • Manufacturer
  • 1 Event

Manufacturer

7 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
  • Model / Serial
    10-0112, 10-0113, 10-0115 | all
  • Product Description
    IVD: Phospholipase A2 kit
  • Manufacturer
  • Model / Serial
    All lot codes under recall.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, OUS: UK and Germany.
  • Product Description
    PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
  • Manufacturer
  • Model / Serial
    sub lot of lot 088061, expiration date 2008-12
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 || Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
  • Manufacturer
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