U.S. exports of malaria diagnostic reagents and test kits (HS 382211) totaled $5.5M in August 2026.
Importers of Malaria Diagnostic Reagents and Test Kits paid $37K in duties in August 2026, an effective tariff rate of 10.76% of the $342K imported — duty actually collected as a share of that value, not the published tariff schedule. Malaria Diagnostic Reagents and Test Kits imports of $342K in August 2026 ran 140% above the year-to-date monthly average of $143K.
Last updated: August 2026 dataRapid diagnostic tests and laboratory reagents specifically designed to detect Plasmodium species — the parasites responsible for malaria — are classified here, covering both antigen-based lateral-flow kits and laboratory-format reagents. Switzerland and the Netherlands are the leading US import sources, consistent with the concentration of global in vitro diagnostics manufacturing among large European life-sciences companies headquartered in those countries. All such products entering the US for clinical use are subject to FDA review as in vitro diagnostic devices and must comply with applicable premarket authorization requirements. Importers should verify that each product's FDA clearance, approval, or Emergency Use Authorization status is current before shipment.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
32 shipments/mo
Yes. Malaria diagnostic test kits intended for clinical use are regulated by FDA as in vitro diagnostic devices and generally require 510(k) clearance, PMA approval, or an active Emergency Use Authorization before commercial distribution. Products imported solely for research use may be exempt, but that exemption must be clearly documented and the product cannot be used in patient care.
Shipments of unapproved IVD devices are subject to FDA detention and refusal of admission at the port of entry. Importers should work with a licensed customs broker and a regulatory affairs consultant to confirm device authorization status before shipment, and should be prepared to provide FDA establishment registration numbers and device listing information as part of entry documentation.
HSChapter 38
ImportsExports
Imports
$342KYoY · free account
Exports
$5.5MYoY · free account
12-mo low · imports
YoY · free accountOver the twelve months to August 2026, the U.S. imported $1.5M of Malaria Diagnostic Reagents and Test Kits.
Through August 2026. Source: U.S. Census Bureau.
Trade Directory
List your company under HS 382211 — Malaria Diagnostic Reagents and Test Kits, so the companies trading it can find you. Be the first supplier listed.
Subheading 4 of 5 in heading 3822
Subheading 382211 · $5.5M of $837.4M
HS10 import codes under this HS6 parent, each with its own page. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Import Value | Effective Tariff % | Dutiable Share | Duty Collected |
|---|---|---|---|---|---|
| 3822110000 | Malaria Diagnostic Test Kits | $342K | 10.76% | 100.00% | $37K |
HS10 export codes under this HS6 parent, each with its own page. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3822110000 | Malaria Diagnostic Test Kits | $5.5M |
Import lines come from the U.S. Harmonized Tariff Schedule and export lines from Schedule B. The two are numbered by different agencies, so the same 10-digit code can appear in both tables describing a different product.
Exports · August 2026
destination
Mexico and Ireland together take 41% of it.
customs district
origin
entry
rate provision · imports
duty collected equals 10.76% of total import value.