TEM Systems Inc

2 devices in the database

  • 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.
  • Model / Serial
    Lot 41925401
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.
  • Product Description
    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    TEM Systems Inc, 4309 Emperor Blvd Ste 100, Durham NC 27703-8069
  • Source
    USFDA