Human Gamma Globulin
Seraplex’ Gammaglobulin is expired therapeutic grade product or product suitable for in vitro diagnostic manufacturing. The Gammaglobulin can be supplied in small quantities in individual 10 gram bottles or in large bulk kilogram quantities. Our Gammaglobulin is suitable for use in Immunoassay development and in the manufacture of diagnostic reagents and controls.
The Gammaglobulin is supplied in 10 gram glass bottles and a certificate of analysis is supplied with each Gammaglobulin batch.
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
- Plastic or glass bottles
- Depends on customer specification.
- Shipped refrigerated or at ambient temperature
- Order Lead Time: Depends on required quantity. Contracts and Standing Orders available.
Seraplex can assist in vitro diagnostic manufacturers interested in buying Human Gamma Globulin for in vitro diagnostic manufacturing. Please call (626) 792-9945 or email us at email@example.com to learn more information.