Access Ostase Calibrators

  • Model / Serial
    623207 626000 628294 628296
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL. Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.
  • Product Description
    Access Ostase Calibrators, Catalog No. 37305, B83876 || Product Usage: || The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    Access Gauges: Ref. 37305 and Lots: 528936 and 528938 || Access Ostase QC: Ref. 37309 and Lots: 528937 and 528939
  • Product Description
    Calibration, control and determination of the related analytes in samples from the human organism.
  • Manufacturer
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter Access Ostase Calibrators and Access Ostase QC Kits
  • Manufacturer
  • Model / Serial
    Catalog Number: 37305 & B83876 (Calibrators); 37309 & B83877 (QC) Batch Number: Viz FSN
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
5 more