FDA/USDA: All of our products are labeled in accordance with the APHIS Animal Product Manual (08/2003-32 PPQ, VRS).  Select the link to view a sample letter that Anogen will supply to the USDA:   Antigen USDA Letter ELISA Kit USDA Letter Diagnostic Kit USDA Letter Immunoglobulin USDA Letter Monoclonal USDA Letter Polyclonal (not including poultry or livestock) USDA Letter   USDA import permits are not required pursuant to Guidelines for Importation #1121 (Effective October, 1998) for products not intended to be used to diagnose disease or illness of humans and animals.  Monoclonal antibodies, ELISA kits and recombinant proteins do not require additional documentation for import.    Animal products or animal by-products containing poultry or livestock derivatives (chicken or goat polyclonal antibodies) require an APHIS Import Permit issued by the Veterinary Services, National Center for Import and Export (NCIE).  Applications for import permits are located online and must be completed and submitted by the Importer (Customer) electronically or by fax to (301) 734-8226.   Website: www.aphis.usda.gov Select "Apply Online for Import Authorization" from the drop down menu at the top of the page. Select "Continue with Online Application" link at the bottom of the page. Select "Animal Product" press "Continue" Or you can access the form directly at:   https://web01.aphis.usda.gov/VS-PITS3.nsf/PITSAPP?OpenForm   Additionally, an annual application for the Permit to Import or Transfer Etiological Agents or Vectors of Human Disease PHS from the CDC can be obtained and will assist the entry of infectious agent products.  To apply for this permit (Click here for Adobe file: Form CDC 0.753 REV 02/04), contact:   Department of Health and Human Services Public Health Services   Centers for Disease Control and Prevention Office of Health and Safety, MS E-79 Atlanta, GA 30333 Tel: 404-498-2260 Fax: 404-498-2275   It is the Customer's responsibility to insure all import documents are available for immediate dispense at the request of the USDA.  In some circumstances, the USDA may contact the Customer to obtain additional information as to the applications or use of the product.  The Customer must ensure that all communications with the USDA are prompt and thorough.  If the USDA refuses clearance of the product based on the Customer's insufficient cooperation or documentation, Anogen will invoice the Customer for return shipping costs and the cost of the product if it fails to pass quality testing due to improper storage or handling while in the possession of the USDA.