Human Gamma Globulin

Human Gamma globulin, Lyophilized
Product # PS980

•  Made from plasma of US origin collected from qualified human whole blood or source plasma donors at Blood Establishments with a current valid FDA Registration Certificate, collected according to FDA guidelines.
• Material manufactured according to documented procedures and GMP guidelines.
• Material may be out-dated or expired for therapeutic use.
• Labeling: Product name, lot number, grams/volume, storage temperature
• Appearance: White powder, free of particulate matter.
• Included with each shipment:
  • Signed Certificate of Compliance with the following information
  • Certification of testing
    •  Each donor unit used in the production of the product has been 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.
      In addition, the plasma used for manufacture may be tested by PCR for HAV, HBV, HCV, HIV
      and Parvo B-19.
• Certification of Storage Temperature
  • The product has been stored at 2 – 8 C.
•  Certificate of Analysis with the following information:
  • Manufacture date, Batch number, pH, total protein, albumin and globulin levels
• Packaging
  • Plastic or glass bottles
• Shipping
  • Depends on customer specification.
• Shipped refrigerated or at ambient temperature
• Order Lead Time: Depends on required quantity. Contracts and Standing Orders available.