ISO9001:2000 Certification
Perry Johnson Registrars, Inc.
United Kingdom Accreditation Service QMS CLICK HERE TO VIEW CERTIFICATE
ANIMAL EXPORT HEALTH CERTIFICATE
The USDA has on file a notarized affidavit from Lee BioSolutions, Inc. verifying the accuracy of the statement below:
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That on the basis of inspection of certificates issued and signed by an official veterinarian of the Government of USA.
- The serum/tissue to which this certificate refers was imported direct from USA and was produced entirely from animals resident in USA.
- The serum/tissue was derived from animals of US origin which were free of clinical evidence of the following diseases swine vesicular disease, rinderpest, foot-and-mouth disease, Vesicular stomatitis, African swine fever, and classical swine fever.
- This product was derived from animals coming from an area within which neither on their holding of origin or place of slaughter had there been an outbreak of any of the following diseases swine vesicular disease, rinderpest, foot-and-mouth disease, Vesicular stomatitis, African swine fever, and classical swine fever.
- The serum/tissue to which this certificate refers was processed in equipment only used to process serum of USA origin and which is not used at any time to process serum/tissue of a lesser status and that the serum has not had other serum/tissue added nor has undergone any alteration other than filtration.
- The serum/tissue to which this certificate refers was packed in new containers after processing and effective steps were taken to prevent recontamination. The batch number which appears on the container has been recorded on this health certificate.
HUMAN CERTIFICATION
The Donors are of US origin and have been tested and found to be NEGATIVE for HbsAg, HCV, HIV-1 & 2, Syphilis and HIV-1 Antigen by currently approved FDA methods. We certify this to be true to the best of our knowledge. However, because no test method can offer complete assurance that HIV, HBsAg, HCV, Syphilis or other infectious agents are absent, this material should be handled at the Bio-safety Level 2 as recommended for any potentially infectious human serum or blood specimen in the CDC/NIH manual "Biosafety in microbiological and Biomedical Laboratories", 1999.
THIS MATERIAL IS SOLD FOR IN-VITRO DIAGNOSTIC USE ONLY IN MANUFACTURING OR RESEARCH. THIS MATERIAL IS NOT SUITABLE FOR INJECTION. When required, negative test results can also be found when pooled product sample and or individual donor samples were tested for viral DNA by HIV-1 Antigen DNA Polymerase Chain Reaction (PCR).
HTLV-1 Certification available by DNA PCR testing for a charge.