Specifications
CLASS
Human Blood Products
SUBCLASS
Human Serum & Plasma
COUNTRY OF ORIGIN
United States of America
APPLICATION
•Assay Development & Validation
•In Vitro Diagnostics
•Vaccine Development
*USAGE / SAFETY STATEMENT
This product is for research use only. It is not intended for diagnostic or therapeutic use.
REGULATORY NOTICE & RESTRICTIONS
Complement activity is reported based on the complement hemolytic titer at 50% dilution (CH50). Each donor unit was tested prior to pooling according to FDA guidelines for the detection of Hepatitis B Surface Antigen, Antibodies to HIV and HVC, HIV-1 RNA, HBV DNA, HCV RNA, WNV RNA, and Syphilis. Each donor has been tested according to FDA guidelines for T. Cruzi (Chagas). All units yielded NON-REACTIVE/NEGATIVE results for each test performed. All blood is collected in the United States of America from human donors in FDA licensed centers and tested with FDA approved test kits. No test method can provide total assurance that Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus or other infectious agents are absent.
PHYSICAL FORM
Frozen liquid
APPLICATION.1
Assay Development & Validation, In Vitro Diagnostics, Vaccine Development
QUALITY CERTIFICATION / COMPLIANCE
Pel-Freez LLC maintains licensure by USDA APHIS Animal Care certifying that they uphold the regulations contained in the Animal Welfare Act. Pel-Freez LLC has a third-party, independent verification that the care and handling of their animals meets the standards set by the American Humane Association. Pel-Freez LLC quality management system is certified to meet internationally-recognized standards for processing and distributing biological products to the scientific research, diagnostic and pharmaceutical industries.
PRODUCT TYPE
Off-the-Clot (OTC)