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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.
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.
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