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SITCSection 5
U.S. exports of composite diagnostic & laboratory reagents (nes) (SITC 59869) totaled $825.6M in July 2026.
Importers of Composite Diagnostic & Laboratory Reagents (NES) paid $29.0M in duties in July 2026 — an effective duty rate of 10% on $290.7M in dutiable value, based on actual customs collections rather than the published tariff schedule.
Last updated: July 2026 dataComposite diagnostic and laboratory reagents not elsewhere specified encompass a broad range of multi-component chemical preparations used in clinical, environmental, and industrial testing — including immunoassay kits, colorimetric test sets, and multiplex detection systems. FDA regulates in-vitro diagnostic reagents as medical devices, requiring that imported products be cleared or exempt before commercial distribution in the United States. Supply chains for these reagents are often highly concentrated among specialized manufacturers, making quality-system audits and regulatory equivalency documentation critical for importers.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
12.4K shipments/mo
Basic heading 9 of 465 in section 5
Basic heading 59869 · $367.6M of $28.9B
FDA treats most composite in-vitro diagnostic reagents as Class I or Class II medical devices. Importers must ensure the product has received 510(k) clearance, qualifies for an exemption, or is covered by a De Novo authorization before it can be legally marketed. FDA may detain shipments that lack proper device listing or establishment registration.
Composite reagents contain two or more chemically distinct active components formulated together to perform a diagnostic or analytical function, whereas single-analyte reagents are pure or simple chemical substances. This distinction matters for SITC and HTS classification: composite preparations fall under the NES reagent heading, while pure chemical substances are typically classified by their chemical identity in other chapters.
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Exports · July 2026
destination
customs district
Census does not publish district detail for this classification system.
origin
Census does not publish state detail for this classification system.
entry
Census does not publish port detail for this classification system.
ImportsExports
Imports
$367.6MYoY · Pro
Exports
$825.6MYoY · Pro
12-mo low · imports
YoY · ProThrough July 2026. Source: U.S. Census Bureau.