Dimension EXL

  • Model / Serial
    Software versions 8.5.1 and 8.5.1SP3.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of AR, CA, CO, IA, ID, IL, IN, LA, MD, MI, MO, MS, NC, NE, OH, OK, PA, SD, TN, TX, VA, and WI.
  • Product Description
    Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. || The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Dade Behring, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

38 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: Thyroid Stimulating Hormone (TSHL), LOCI Free Thyroxine (FT4L), Thyroid Stimulating Hormone (TSH), Cardiac Troponin I (CTNI), Mass creatine kinase MB isoenzyme (MMB), Sirolimus (SIRO), All lots (including all future lots until Instructions For Use update), Affected: DM Troponin I (TNI), DV Digoxin (DIGXN), DV Estradiol (E2), DV Ferritin (FERR), DV Prolactin (PRL), DV Thyroid Stimulating Hormone (TSH) All lots including all future lots until instructions of use is updated
  • Manufacturer
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