Effective for lots manufactured as of 01 Oct 2020, this product has been changed to Part Number 535-100-HI (previously 535-HI). There is no impact on the manufacture of the product.
Human Male AB serum is collected from FDA Licensed blood centers within the US. Each individual unit is tested and found negative for all viral markers via FDA-approved methods: HIV-1, HCV and HBV by Nucleic Acid Test, Parvo B-19, WNV and HAV by Nucleic Acid Test, Anti-HIV 1/2, Anti-HCV, HBsAg & syphilis. Additional testing provided by Access: ZIKA, Chagas, Anti-HBC, Mycoplasma, Endotoxin, USP Sterility, Hemoglobin, Osmolality, pH, Chemistry and Species testing. Material is collected from donors meeting the health requirements established by 21CFR 640 subpart G via plasmapheresis. Units are pooled, processed and .1 micron sterile filtered under cGMP guidelines. This product is manufactured using human thrombin.
Disclaimer: This product is intended for in vitro, further manufacturing use or cell culture. All units have been collected in the USA in FDA licensed facilities and tested with FDA approved methods.