Test Kits
Effective October, 1998
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GUIDELINES FOR IMPORTATION #1121 Including: Not including: Introduction: Test kits may contain small amounts of animal-derived components.
The animal-derived components are primarily from countries which the USDA considers
to be free of exotic disease agents. Most test kits are consigned to universities,
diagnostic laboratories, or pharmaceutical companies which dispose of them by
autoclaving and/or incineration. Therefore, test kits that will not be used
to diagnose infectious animal diseases present a negligible risk of exposure
of Animal-derived kit components imported in bulk, i.e., not packaged for final use, will require an import permit unless there is an applicable guideline. (For example, there is a guideline for the importation of rabbit antibodies. If the antibodies are a kit component and they can meet the criteria in the guideline, they will not require a permit.) Test kits used to diagnose infectious diseases of animals
require an import permit from USDA, VS, Center for
Veterinary Biologics, Licensing, and Policy Development (CVB/LPD). The telephone
number in Procedures: A USDA, VS import permit will not be required for test kits if the shipment can meet the following conditions:
If the material cannot meet these criteria, then a USDA import permit may be required. Permit applications may be obtained by calling (301) 734-3277. Please instruct your shippers to supply the above information with the shipping documents for each shipment and ensure that it is available for the USDA Inspector's review at the port of arrival. DO NOT put the documents INSIDE the shipping container. If the above information is not supplied, the shipment may be subject to delays and import compliance fees. |
| VS - Safeguarding Animal Health Phone (301) 851-3300, FAX (301) 734-6402 |
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