Updated February, 2013
GUIDELINES FOR IMPORTATION #1121
Test kits may contain small amounts of animal-derived components. Most test kits are consigned to universities, diagnostic laboratories, or pharmaceutical companies which dispose of them by autoclaving and/or incineration. Therefore, applicable imported test kits present a negligible risk of exposure of U.S. animal populations to exotic disease agents and do not require a USDA, Veterinary Services (VS) import permit.
Test Kits Not Requiring a USDA Import Permit:
A USDA Import Permit is not required for test kits if the shipment meets the following conditions and it is recommended that the shipment be accompanied by:
If the material to be imported cannot or does not meet the criteria outlined above on this Guideline, then a USDA, VS or USDA, CVB Import Permit is required.
USDA, VS Import Permit
Test Kits and material(s) that require a USDA, VS import permit:
USDA, VS Import Permit applications may be obtained several ways:
USDA, CVB Import Permit
Test Kits that can diagnose infectious diseases of animals, imported for any purpose, or for any type of research require a Research and Evaluation Permit from USDA, VS, Center for Veterinary Biologics, Policy, Evaluation and Licensing (CVB, PEL).
Please include the information recommended/required by this Guideline along with the shipping documents for each shipment and ensure that it is available for review by USDA authorized inspectors at the port of entry. DO NOT put documents INSIDE the shipping container. If the above information is not available, the shipment may be subject to delays and import compliance fees.
The Food and Drug Administration and/or the Centers for Disease Control should be contacted for information regarding the import of kits that diagnose human disease.
1A self-contained test kit includes everything needed to use the kit assembled in a pre-packaged kit ready for final use.