Harmonized System
U.S. exports of Blood-Grouping Diagnostic Reagents and Kits (HS 382213) totaled $9.1M in August 2026.
Importers of Blood-Grouping Diagnostic Reagents and Kits paid $328K in duties in August 2026, an average duty rate of 9.93% — duty actually collected as a share of the imports that cleared customs, not the published tariff schedule. Blood-Grouping Diagnostic Reagents and Kits imports of $3.3M in August 2026 ran 15% above the year-to-date monthly average of $2.9M.
Last updated: August 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.
101 import shipments a month
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.
Trade Directory
List your company under HS 382213 — Blood-Grouping Diagnostic Reagents and Kits, so the companies trading it can find you. Be the first supplier listed.
Subheading 3 of 5 in heading 3822
Subheading 382213 · $9.1M of $837.4M
ImportsExports
Imports
$3.3MYoY · free account
Exports
$9.1MYoY · free account
12-mo low · imports
Low · free accountOver the twelve months to August 2026, the U.S. imported $38.0M of Blood-Grouping Diagnostic Reagents and Kits and exported $107.8M.
Through August 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 | Imports for consumption | Average duty rate | Dutiable Share | Duty Collected |
|---|---|---|---|---|---|
| 3822130000 | Blood-Grouping Reagents | $3.3M | 9.93% | 100.00% | $328K |
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 | $9.1M |
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
Canada and France together take 42% of it.
customs district
origin
entry
rate provision · imports
duty collected equals 9.93% of imports for consumption.