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HSChapter 38
U.S. imports of malaria diagnostic reagents and test kits (HS 382211) totaled $171K in April 2026, traded with 9 countries.
Importers of Malaria Diagnostic Reagents and Test Kits paid $15K in duties in April 2026 — an effective duty rate of 10% on $151K in dutiable value, based on actual customs collections rather than the published tariff schedule. Malaria Diagnostic Reagents and Test Kits imports of $171K in April 2026 ran 50% above the year-to-date monthly average of $114K.
Last updated: April 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.
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.
Monthly import values over time
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| Country | Imports | Exports | Balance |
|---|---|---|---|
| MEXICO | -- | $2.4M | +$2.4M |
| IRELAND | -- | $1.1M | +$1.1M |
| UNITED KINGDOM | -- | $885K | +$885K |
| CHINA | -- | $302K | +$302K |
| KOREA, SOUTH | -- | $223K | +$223K |
HS10 import codes under this HS6 parent. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Import Value | Effective Tariff % | Duty Collected |
|---|---|---|---|---|
| 3822110000 | MALARIA DIAGNOSTIC TEST KITS | $171K | 10.08% | $15K |
MALARIA DIAGNOSTIC TEST KITS
HS10 export codes under this HS6 parent. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3822110000 | MALARIA DIAGNOSTIC TEST KITS | $6.0M |
MALARIA DIAGNOSTIC TEST KITS
45.8K kg
PRODUCTS AND RESIDUALS OF CHEMICAL INDUSTRY, NESOI
HS 382499
DIAGNOSTIC OR LABORATORY REAGENTS INCL KITS, NESOI
HS 382219
CHEM ELEM DOPED, USED IN ELECTRON, DISCS WAFERS ET
HS 381800
SUPPORTED CATALYSTS W PREC METAL/PREC MTL COMPND
HS 381512
SUPPORTED CATALYSTS, NESOI
HS 381519
ADDITIVE FOR LUB OIL CONT PETRO/BITUMINOUS MINOIL
HS 381121
| State | Imports | Exports | Balance |
|---|---|---|---|
| California | $8K | $2.0M | +$2.0M |
| Utah | -- | $1.7M | +$1.7M |
| Pennsylvania | -- | $883K | +$883K |
| Port | Imports | Exports | Balance |
|---|---|---|---|
| LAREDO, TX | -- | $2.3M | +$2.3M |
| CHESTER, PA | -- | $809K | +$809K |
| NEW ORLEANS, LA | $171K | $588K | +$417K |