Cord Red Cells

Cord Red Blood Cells for In Vitro Diagnostic Use

Product #’s PS741 & PS743

• Cord Red Cells: Units of individual collections of human cord whole blood, collected at delivery from individual births.
• Supplied from Accredited and Inspected Hospitals and Cord Blood Banks. Facilities supplying the cord blood have a current valid FDA establishment registration, and have obtained donor consent.
• A sample of plasma from each collection is tested at an FDA licensed laboratory and found non-reactive for the presence of HBsAg, negative for antibody to HIV 1/2 and HCV. Syphilis and HIV and HCV PCR testing may also be performed.
• Red Cells collected from Cord Whole Blood Units. Cord Whole Blood units will be:
  • ~100 mL
  • collected in CPD anticoagulant
  • collected and maintained in the original FDA approved collection container or whole blood may be transferred to 50 mL sterile tubes. Red Cells provided as individual collections in tubes or pooled red cells in 250 mL to 1 Liter containers.
  • Stored at 2 – 8 C.
  • Can be provided in the following configurations:

• Labeling: Each unit labeled with the product description, unit number or tube number, anticoagulant, collection date and volume.
• Appearance: Normal in color, free of hemolysis and clots.
• Included with each shipment:
  • Signed Certificate of Analysis with the following information:
  • Certification of testing as above
  • Certification of Storage Temperature
  • Collection Data: Unit number or tube number, collection date, and volume
• Packing:   Cord red cell tubes or pooled cord red cell containers packed in shipping containers suitable for 48 hour temperature control with cold packs.
• 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.