抗原抗体试剂 (ELISA)
CN → US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 3822190030 | 10.0% | CN | US | Official Doc |
| 3822190040 | 10.0% | CN | US | Official Doc |
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🧪 Antigen-Antibody Reagents (ELISA)
International Trade Classification & Customs Clearance Guide | 2026 Latest Tariff Analysis
🌐 HS Code Reference & Clearance Strategy | Professional Decoding for Diagnostic Reagents
Antigen and antibody reagents, specifically ELISA (Enzyme-Linked Immunosorbent Assay) kits, are critical components in biomedical diagnostics, immunology research, and clinical testing. In international trade, these products fall under two primary categories depending on their specific function: Laboratory/Diagnostic Reagents or Immunological Products.
⚠️ Critical Distinction Point:
- If the product is used for diagnostic purposes or as a laboratory reagent containing antigens/antibodies →归入 3822
- If the product is classified as an immunological product (e.g., blood components, immunoglobulins) →归入 3002
📦 Section 1: HS Code Classification Details (2026 Authorized Mapping)
Based on the provided data, here is the precise mapping for Antigen-Antibody Reagents:
| HS Code | Summary/Classification Logic | Tax Rate (Total) | Tax Detail Breakdown |
|---|---|---|---|
3822.19.00.30 |
Diagnostic/Lab Reagent: Contains antigens or antiserum. ELISA reagents fit this definition perfectly. | 10.0% | Base: 0.0% Additional: 0.0% Section 301 (122): 10% |
3002.13.00.10 |
Immunological Product: Fits the definition of blood or immune-related components. | 10.0% | Base: 0.0% Additional: 0.0% Section 301 (122): 10% |
3002.13.00.90 |
Immunological Product: Fits the scope of immune products not explicitly defined as monoclonal antibodies. | 10.0% | Base: 0.0% Additional: 0.0% Section 301 (122): 10% |
3822.19.00.10 |
Diagnostic Reagent: Contains antigens and antibodies, matching the use case of reagents containing antigens or antisera. | 10.0% | Base: 0.0% Additional: 0.0% Section 301 (122): 10% |
🔍 Key Insight:
- All listed HS codes share the same total tax rate of 10%.
- The difference lies in the legal classification path:
-3822series emphasizes the chemical/reagent nature (ELISA kits).
-3002series emphasizes the biological/immune nature (blood derivatives, immunoglobulins).
- Section 122 Tariff (10%) applies to all these categories if originating from China to the US.
💰 Section 2: 2026 Tariff Structure Detailed Breakdown
✅ Applicable Jurisdiction: United States (US)
✅ Origin: China (CN) (Implied by Section 122/301 tariffs)
✅ Effective Date: Current Trade Policy (Section 122/301)
🎯 Universal Tax Calculation for Antigen-Antibody Reagents
| Item | Content |
|---|---|
| Base MFN Rate | 0.0% (Most Favored Nation rate for diagnostic/immunological products is generally duty-free) |
| Section 301 / 122 Surcharge | +10% (Specific "122 Clause" tariff applied to these HS codes) |
| Total Effective Tariff | 10.0% |
| Tax Calculation Formula | CIF Value × 10% |
| De Minimis Exemption | ❌ Not Applicable (High-value diagnostic kits usually exceed $800 threshold or are restricted items) |
| Legal Basis Path | HTSUS:3822.19/3002.13 → Section 122 / Trade Act 301 → Customs Ruling |
📌 Explanation:
- The 0% base rate reflects the US policy to encourage trade in medical and scientific supplies.
- The 10% surcharge is a retaliatory or strategic tariff (often associated with Section 301 or specific Section 122 actions) targeting high-tech or specific industrial goods from China.
- Note: Despite the "Base 0%", the actual landed cost impact is 10% due to these additional duties.
🛠️ Section 3: Customs Clearance Practical Advice
✅ 1. Required Documentation Checklist
| Document | Mandatory? | Notes |
|---|---|---|
| ✅ Product Specification Sheet | ✔️ | Must clearly state: "Antigen/Antibody," "ELISA Kit," "For Research Use Only" (RUO) or "In Vitro Diagnostic" (IVD). |
| ✅ Labeling/Packaging Photos | ✔️ | Must show ingredients, storage conditions, and hazard symbols (if any). |
| ✅ Certificate of Analysis (COA) | ✔️ | Proves purity and composition, crucial for distinguishing between 3822 (reagent) vs 3002 (biological). |
| ✅ Commercial Invoice | ✔️ | Must match HS Code exactly. Avoid vague terms like "Lab Supplies." Use "ELISA Reagent Kit." |
| ✅ Bill of Lading / Air Waybill | ✔️ | Ensure harmonized system code is pre-filled if possible. |
| ✅ FDA Registration (if IVD) | ✔️ | If classified as a diagnostic device, FDA prior notice is mandatory. |
✅ 2. Declaration Strategy & Tips
🔥 "Clarify Function, Not Just Name"
| Scenario | Correct Declaration | Incorrect Declaration | Risk |
|---|---|---|---|
| ELISA Kit for Research | 3822.19.00.10 or .30"Enzyme-linked immunosorbent assay reagents for laboratory research" |
"Chemical Reagents" "Lab Chemicals" |
Misclassification risk; delays. |
| Blood/IgG Based Immunoassay | 3002.13.00.90"Immunological products, not monoclonal" |
"Medical Equipment" | Higher scrutiny; potential penalty. |
| Antiserum/Vaccines | 3002.13.00.10"Antiserum and other blood fractions" |
"Dietary Supplements" | Severe compliance violation. |
📌 Best Practice:
- For ELISA kits,3822.19.00is the most common and safest classification for general diagnostic/research use.
- If the kit contains 活体生物成分 (live biological components) or is strictly a blood derivative, consider3002.13.
- Always declare "Contains Antigen/Antibody" to avoid ambiguity.
✅ 3. Special Considerations
| Situation | Handling Advice |
|---|---|
| Biological Hazard | Check if materials are classified as UN 3373 (Biological Substance, Category B). Requires 3-piece packaging. |
| Cold Chain | ELISA reagents often require 2-8°C. Provide Temperature Loggers in shipment. |
| FDA vs. Non-FDA | If intended for human diagnosis (IVD), FDA clearance (510(k)) is needed. If "For Research Use Only" (RUO), FDA clearance is not required, but labeling must clearly state this. |
| Section 122/301 Exemptions | Check if your specific HTS subheading has an exclusion list. Most diagnostic reagents are NOT excluded from current surcharges. |
🌍 Section 4: Global Market Comparison (2026)
| Country/Region | Recommended HS Code | Total Tariff | Key Requirement | Notes |
|---|---|---|---|---|
| 🇺🇸 USA | 3822.19.00.10/30 3002.13.00.10/90 |
10% | FDA Prior Notice (if IVD) UN 3373 Packing |
10% Surcharge applies. No duty-free status for China-origin. |
| 🇨🇳 China | 3822.19.00 3002.13.00 |
0% - 5% | NMPA Registration (if IVD) | Lower barriers for entry into China. |
| 🇪🇺 EU | 3822.00 3002.30 |
0% - 4.5% | CE Marking (IVDR) | No Section 301 tariffs. Strict IVDR compliance for diagnostics. |
| 🇯🇵 Japan | 3822.00 3002.30 |
0% | PMDA Approval (if IVD) | Generally duty-free for diagnostic reagents. |
📌 Conclusion:
- USA is the most costly market due to the 10% Section 122/301 tariff.
- EU and Japan offer better tariff conditions but have stricter regulatory frameworks (IVDR, PMDA).
- Strategic Tip: If shipping to the US, ensure the product is clearly labeled "For Research Use Only" if possible, to avoid complex FDA IVD regulations, though the 10% tariff remains.
📌 Section 5: Common Errors & Pitfalls
❌ Error 1: Declaring ELISA kits as "Laboratory Glassware" or "General Chemicals"
👉 Consequence: Misclassification, potential seizure, or back-tariffs.
👉 Fix: Always use 3822 for reagents.
❌ Error 2: Ignoring the "Section 122" tariff component
👉 Consequence: Underestimating landed cost by 10%.
👉 Fix: Budget for 10% duty in all cost calculations for China-origin goods to the US.
❌ Error 3: Failing to specify "Antigen/Antibody" on the Invoice
👉 Consequence: Customs may classify under a higher-tax general chemical category.
👉 Fix: Explicitly state contents: "Contains Mouse Anti-Human IgG Antibody..."
✅ Correct Declaration Example:
Commodity Name: ELISA Kit, Human IL-6 Detection
HS Code:3822.19.00.30
Description: Laboratory reagent containing antigens and antibodies for in vitro diagnostic testing. For Research Use Only.
Origin: China
Duty: 10% (Base 0% + Section 122 10%)
🎯 Conclusion: Professional Clearance, Cost Optimization
🎯 Key Takeaway:
🔹 "ELISA Kits =
3822.19(Most Common)"
🔹 "Immune Products =3002.13(Specific Biological)"
🔹 "US Tariff = 10% Total (No Exemption for China)"🔹 "Always declare 'Antigen/Antibody' to avoid misclassification."
🔹 "Check FDA requirements if intended for human diagnosis."
📌 Pro Tip:
If you are exporting to the USA, consider applying for an Advance Ruling (Customs Ruling) before the first shipment. This locks in the HS code and tariff rate, preventing unexpected audits or disputes at customs.
📣 Immediate Action:
📞 Contact your customs broker with the Product Specification Sheet and Certificate of Analysis.
🚀 Ensure your commercial invoice explicitly states:
"HS Code: 3822.19.00.30 | Contains Antigens/Antibodies | Subject to 10% Section 122 Tariff"
✨ Precision in Classification Saves Money and Time!
💼 Every percent in tariff matters – optimize your supply chain today!
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About HS Code Classification
The Harmonized System (HS) is an internationally standardized nomenclature developed by the World Customs Organization (WCO) to classify traded products. Over 200 countries use the HS system as the basis for customs tariffs, trade statistics, and import/export regulations.
Each HS code follows a hierarchical structure:
- Chapter (2 digits) — Broad category of goods (e.g., Chapter 84: Machinery and Mechanical Appliances)
- Heading (4 digits) — More specific grouping within the chapter
- Subheading (6 digits) — Internationally standardized breakdown, used by all WCO member countries
- National subdivisions (8-10 digits) — Country-specific extensions for further classification, such as US HTSUS 10-digit codes
Correct HS code classification is essential for smooth customs clearance, accurate duty payment, and compliance with trade regulations. Misclassification can lead to customs delays, overpayment of duties, or penalties.
When importing from CN to US, the applicable tariff rates may include:
- Most-Favored-Nation (MFN) rate — The standard duty rate applied to WTO members
- General rate — Applied to countries without trade agreements
- Trade remedy duties — Additional tariffs such as Section 301 (anti-dumping), Section 232 (national security), or countervailing duties
The information provided on this page is for reference purposes only. For official classification, please consult with your local customs authority or a licensed customs broker.