Device Recall PLAC Test ELISA Kit

  • Model / Serial
    Lot Number: 907090; Part Number: 90123; Product Code NOE
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
  • Product Description
    diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 || The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, OUS: UK and Germany.
  • Product Description
    PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL
  • Manufacturer
  • Model / Serial
    Lot number 910013, expiration date 05/31/2010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel.
  • Product Description
    diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
  • Manufacturer