Malaria Rapid Diagnostic Test Kit (RDT) - CareStart from China

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 — China → United States

10%

Rate breakdown

9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 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