Hepatitis B Surface Antigen Test Kit from Japan
A diagnostic kit containing hepatitis B surface antigens (HBsAg) for patient administration in challenge tests to detect immune response. Classified under HTS 3006.30.10.00 as diagnostic reagents with antigens put up in measured doses for direct patient use. It aids in confirming immunity status post-vaccination.
Duty Rate — Japan → United States
15%
Rate breakdown
9903.04.6215%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter
9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 to this subchapter
Import Tips
• Include FDA Investigational New Drug (IND) if for clinical trials; standard kits need 510(k)
• Provide stability and potency test results; customs may inspect for degradation
• Label as 'for diagnostic use only' to prevent reclassification as therapeutic vaccine