Malaria Rapid Diagnostic Test Kit (RDT) - CareStart from Japan
The CareStart Malaria RDT is a prepared diagnostic reagent kit containing antigens for Plasmodium falciparum HRP-2 and lactate dehydrogenase (pLDH), designed specifically for rapid malaria detection via lateral flow immunoassay on a backing. It falls under HTS 3822.11.0000 as a diagnostic reagent for malaria, put up in kit form for point-of-care testing in endemic areas.
Duty Rate — Japan → United States
12.5%
Rate breakdown
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter
Import Tips
• Obtain FDA 510(k) clearance or Emergency Use Authorization for diagnostic kits; ensure reagents are stable under WHO prequalification standards; declare exact antigen targets (HRP-2/pLDH) to avoid misclassification