VITROS Chemistry Products Calibrator Kit 31

  • Model / Serial
    Lot 3155 Product Codes: 6842906 & 6801876
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, WA, WV & Puerto Rico;** Foreign: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
  • Product Description
    The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Manufacturer Parent Company (2017)
  • Source
    USFDA