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Class II Special Controls Guideline: Dengue Virus Serological Reagents - Guideline for Industry and Food and Drug Administration

Posted May 29 2014 12:00am
This special controls guideline was developed to support the classification into class II (special controls) of dengue (DEN) virus (DENV) serological reagents. DENV serological reagents are devices that consist of antigens and antibodies for the...
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