Ambient Infectious Substance Shipper

Additional Details

CDC, FDA and OSHA Definitions:
Diagnostic specimens are any human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue, and tissue fluids. Specimens shipped to undergo a screening test for initial diagnosis may be considered as general diagnostic specimens provided such material is not known or suspected to contain infectious substances, the HBV or HIV virus. If a specimen is suspected to contain an infectious substance, it is an infectious substance and must comply with infectious substance transport requirements.
Biological products are any biological product prepared in accordance with 9 CFR Part 102 Licenses for biological products , 9 CFR Part 103 Biological products for experimental treatment of animals , 9 CFR Part 104 Permits for biological products , 21 CFR Part 312 Investigational new drug application , or 21 CFR Parts 600-680 Biologics , which in accordance with such provisions, may be shipped in interstate traffic. Biological products are either finished biological products for human or veterinary use or finished biological products shipped prior to licensing for developmental or investigational purposes using humans or animals. Live animal and human vaccines are considered biological products and not infectious substances.