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Each serum/plasma donor unit used to manufacture AbT human serum based
products
is tested by FDA approved methods and found non-reactive for
Hepatitis B
Surface Antigen (HBsAg), antibody to Hepatitis C (HCV)
and/or HCV NAT,
antibody to
HIV-1/HIV-2, and HIV-1 Ag and/or HIV-1 NAT. No known test method
can offer complete assurance that products
containing human derived
materials will be absent of these and other infective
agents. Some
products may contain other human derived materials for which
there are
no approved tests. These products should be handled at Biosafety
Level
2 as recommended for any potentially infectious human serum,
blood
specimens, or urine in the Centers for Disease Control/ National
Institutes for
Health Manual
Biosafety in Microbiological and Bioanalytical Laboratories, 1993
.
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