exTEM Assay for the ROTEM delta Thromboelastometry System

  • Model / Serial
    Lot No. 21929007
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.
  • Product Description
    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. || Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    TEM Systems Inc, 3210 E Nc Hwy 54, Durham NC 27709
  • Manufacturer Parent Company (2017)
  • Source
    USFDA