Hepatitis B Surface Antigen Test Kit from Canada

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 — Canada → United States

0%

Rate breakdown

9903.03.030%Articles the product of any country, as provided for in subdivision (aa)(ii) of U.S. note 2 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