Off the Clot Serum, Pooled

Off Clot Normal Serum, Pooled
Product # PS852

• Pooled serum from tubes of non-anti-coagulated whole blood collected from normal donors, collected at FDA registered Blood Establishments
• Whole blood is collected in serum tubes (red top tubes with no anti-coagulant and no additives). The tubes are centrifuged to separate the serum from the clot. The serum is removed from the clot into tubes and the product is held in the refrigerator until pooled into containers of 2.5 to 3.5 Liters. The product is pooled and frozen within 96 hours of collection.
• The donor list per ~3 Liter pool is maintained by the testing center which certifies the testing.
• The ~3 Liter containers are stored frozen until thawed for pooling into larger batches, then 0.2μ filtered and filled into appropriate containers and frozen.
• Side sample tubes (3 mL) from each batch available for evaluation.
• Labeling
  • Each container is labeled with product description, lot number, batch number, volume, and storage temperature. Includes the statement “For use in Research / Manufacturing Non-injectable Products Only.”
• Appearance
  • Clear and golden colored, non-lipemic, free of hemolysis and particulate matter.
• Included with each shipment:
  • Signed Certificate of Compliance with the following information:
  • Certification of testing by FDA licensed facility using FDA accepted methods.
  • Each donor unit comprising the pool has been tested and found Negative or Non-Reactive for HBsAg, anti-HIV 1/2, anti-HCV, anti-HBc, anti-HTLV-I/II, and HIV-1 RNA, HCV RNA, and WNV by NAT, and Syphilis by RPR.
  • Certification of Storage Temperature at ≤15 C or colder.
• Shipped at -15 C or colder