Source Leukocytes

White Blood Cells (Buffy coat, Source Leukocytes) for In Vitro Diagnostic Use
Product # PS290

• White Blood Cell units will be:
  ~50 mL
  • Prepared from separated whole blood or from apheresis collection
  • Drawn from qualified human blood donors, collected at FDA registered Blood Establishments
  • Provided within 24 – 48 hrs to of collection
• Anticoagulants
  • CPD, CP2D, CPDA-1 or ACD-A
• Labeling
  • Each unit labeled with the product description, unit number, anticoagulant, collection date and/or expiration date, and the name of blood establishment.
• Appearance: Normal in color, free of hemolysis and clots.
  • Included with each shipment:
    • Signed Certificate of Compliance with the following information:
      Certification of testing:
    • Each donor unit tested by an FDA licensed laboratory with FDA licensed test kits.
      Test results Negative or Non-Reactive for HBsAg, anti-HBc, anti-HIV 1/2, anti-HTLV I/II, anti-HCV, and Syphilis, HIV -1 RNA and HCV RNA. Results for other viral tests, if performed. such as HBV NAT, West Nile Virus and Chagas (T. cruzi) Negative or Non-Reactive.
    • Certification of Storage Temperature: The units have been maintained at 1 – 6 C.
• Collection Data
  • A record listing the unit number, collection date will accompany each shipment. Each unit will be cross-referenced to the box in which it is packed.
• Packing
  • White Blood Cell units packed in validated shipping containers suitable for 48 hour temperature control.
    Shipping: Depends on customer specification.
    Shipped at 1 – 10 C with cold packs with an insulating barrier between the units and the cold packs to protect from freezing, Next Day Delivery by Federal Express with cold packs to maintain temperature.
• Order Lead Time: Depends on required quantity. Contracts and Standing Orders available.