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U.S. exports of blood-grouping diagnostic reagents and kits (HS 382213) totaled $8.6M in July 2026.
Importers of Blood-Grouping Diagnostic Reagents and Kits paid $236K in duties in July 2026 — an effective duty rate of 9.5% on $2.5M in dutiable value, based on actual customs collections rather than the published tariff schedule.
Last updated: July 2026 dataAntisera, monoclonal antibody reagents, and prepared kits used to determine ABO, Rh, and other blood-group antigens are essential inputs for transfusion medicine, organ transplantation, and prenatal care. The United Kingdom and Germany are the leading US import sources, reflecting the long-established expertise of European transfusion diagnostics manufacturers. These products are regulated by FDA as biologics and in vitro diagnostic devices; blood-grouping reagents in particular have historically required FDA licensure under the biologics framework, making pre-import regulatory verification especially important. Importers should confirm that the foreign manufacturer holds the appropriate FDA establishment registration and product license.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
94 shipments/mo
Blood-grouping reagents have historically been regulated as biologics under Section 351 of the Public Health Service Act, requiring FDA licensure rather than the 510(k) clearance pathway used for many other IVDs. This means the foreign manufacturer must hold a valid FDA biologics license, and the specific reagent must be listed on that license. Importers should request the manufacturer's FDA biologics license application number and confirm its active status before shipment.
Entry documentation should include the FDA establishment registration number, the biologics license number (or device clearance number if applicable), a certificate of analysis, and labeling that matches the FDA-authorized product. CBP coordinates with FDA for admissibility review, and incomplete documentation can result in detention. Working with a customs broker experienced in FDA-regulated biologics is strongly advisable.
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Subheading 3 of 5 in heading 3822
Subheading 382213 · $2.8M of $398.2M
ImportsExports
Imports
$2.8MYoY · Pro
Exports
$8.6MYoY · Pro
12-mo low · imports
YoY · ProThrough July 2026. Source: U.S. Census Bureau.
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 |
|---|---|---|---|---|---|
| 3822130000 | Blood-Grouping Reagents | $2.3M | 9.20% | 97.33% | $212K |
HS10 export codes under this HS6 parent, each with its own page. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3822130000 | Blood-Grouping Reagents | $8.7M |
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 · July 2026
destination
customs district
origin
entry
rate provision · imports
13.0% enters free of duty; the effective duty rate is 8.30%.