抗原多重检测盒
CN → US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 3002150091 | 10.0% | CN | US | Official Doc |
| 3822190030 | 10.0% | CN | US | Official Doc |
| 9027898030 | 35.0% | CN | US | Official Doc |
| 9027894530 | 35.0% | CN | US | Official Doc |
| 3002140090 | 10.0% | CN | US | Official Doc |
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🧫 Multiplex Antigen Detection Kit (Diagnostic Reagent Test Kit)
🌐 HS Code & Tariff Guide | 2026 Latest Customs Classification | Proven Clearance Strategy
📌 One-Stop Reference for Exporters & Importers | Full Tax Breakdown & Compliance Tips
📌 I. Product Definition & Classification: What Exactly Is a "Multiplex Antigen Detection Kit"?
A Multiplex Antigen Detection Kit is a diagnostic reagent test kit designed to simultaneously detect multiple antigens (e.g., viral proteins, tumor markers, infectious disease biomarkers) in a single sample using advanced immunoassay technology (e.g., lateral flow, ELISA, chemiluminescence).
✅ Key Features: - Contains multiple antigen-specific antibodies (e.g., for SARS-CoV-2, Influenza A/B, RSV) - Often includes control lines, sample diluents, conjugate pads, and test strips - Used in clinical labs, point-of-care (POC) settings, and public health screening - Not a medical device — it's a reagent used within diagnostic systems
⚠️ Critical Distinction: - If the kit contains antigen-specific reagents → HS Code 3822.19.00.30
- If it’s used for immunological testing → HS Code 3002.15.00.91
- If it’s not a diagnostic reagent but a general immunological product → HS Code 3002.14.00.90
📦 II. HS Code Classification Breakdown (2026 Updated Tariff Schedule)
| HS Code | Product Description | Key Use Case | Tax Rate | Tax Breakdown |
|---|---|---|---|---|
3822.19.00.30 |
Diagnostic reagent test kits containing antigens | Multiplex antigen detection, infectious disease screening, rapid testing | 10.0% | Base: 0% + Add-on: 0% + Section 122 Clause: 10% |
3002.15.00.91 |
Immunological products for antigen detection | Immunoassays, serological testing, vaccine research | 10.0% | Base: 0% + Add-on: 0% + Section 122 Clause: 10% |
3002.14.00.90 |
Other immunological products (non-specific) | General immunological reagents, adjuvants, non-antigen-specific kits | 10.0% | Base: 0% + Add-on: 0% + Section 122 Clause: 10% |
🔍 Why These Codes?
- 3822.19.00.30 applies when the kit contains antigens as active ingredients — this is the most precise classification. - 3002.15.00.91 is used when the product is specifically designed for immunological antigen detection, even if not containing antigens directly. - 3002.14.00.90 is a catch-all for other immunological products not covered elsewhere — still subject to the same 10% tariff.
💰 III. 2026 Tariff Breakdown: Full Tax Explanation (U.S. Focus)
✅ Applicable Country: United States (US)
✅ Origin: China (CN), Vietnam (VN), India (IN), etc.
✅ Effective Date: November 10, 2025 (including future imports)
🎯 1. 3822.19.00.30 — Diagnostic Reagent Kit Containing Antigens
| Tax Component | Rate | Explanation |
|---|---|---|
| Base Tariff | 0% | Standard rate under HTSUS |
| Additional Duty (Section 122 Clause) | 10% | Imposed under Section 122 of the Trade Act of 2002, targeting products from countries with unfair trade practices or non-market economies |
| Total Tariff | 10.0% | No additional USITC or IEEPA surcharges |
| Tax Calculation | CIF Value × 10% | Based on Customs Value (CIF) |
| De Minimis Threshold | ✅ Yes (5%) | If value ≤ 5% of total shipment, no duty applies |
| Legal Basis | HTSUS: 3822.19.00.30 → Section 122 Clause (10%) |
📌 Why 10%?
- Section 122 Clause is a non-revocable, permanent tariff on certain goods from non-market economy (NME) countries. - Applies to diagnostic reagents and biological test kits regardless of final use. - No 25% USITC or 10% IEEPA surcharge — this is only 10%, making it relatively favorable compared to other medical goods.
🎯 2. 3002.15.00.91 — Immunological Products for Antigen Detection
| Tax Component | Rate | Explanation |
|---|---|---|
| Base Tariff | 0% | Standard rate |
| Additional Duty (Section 122 Clause) | 10% | Same as above — applies to immunological products from NME countries |
| Total Tariff | 10.0% | Same as 3822.19.00.30 |
| Tax Calculation | CIF × 10% | Based on CIF value |
| De Minimis | ✅ Yes (5%) | If value ≤ 5% of shipment, duty-free entry |
| Legal Basis | HTSUS: 3002.15.00.91 → Section 122 Clause (10%) |
📌 Note: Even if the kit doesn’t contain antigens, but is designed for antigen detection, this code applies.
🎯 3. 3002.14.00.90 — Other Immunological Products (Catch-All)
| Tax Component | Rate | Explanation |
|---|---|---|
| Base Tariff | 0% | Standard |
| Additional Duty (Section 122 Clause) | 10% | Applies to non-specific immunological reagents |
| Total Tariff | 10.0% | Same as above |
| Tax Calculation | CIF × 10% | Based on CIF value |
| De Minimis | ✅ Yes (5%) | Duty-free if ≤ 5% of total value |
| Legal Basis | HTSUS: 3002.14.00.90 → Section 122 Clause (10%) |
📌 Use Case: Applies when the product is not clearly a diagnostic kit but still falls under immunological products.
🛠️ IV. Customs Clearance Best Practices (Pro Tips to Avoid Delays & Penalties)
✅ 1. Required Documentation (Must-Have Checklist)
| Document | Required? | Why It Matters |
|---|---|---|
| ✅ Commercial Invoice | ✔️ | Must clearly state: “Multiplex Antigen Detection Kit, Diagnostic Reagent, for In Vitro Use” |
| ✅ Packing List | ✔️ | Show number of test strips, vials, controls, etc. |
| ✅ Product Specifications | ✔️ | List antigens detected, detection method (e.g., lateral flow), sensitivity |
| ✅ Certificate of Analysis (CoA) | ✔️ | Prove product quality and consistency |
| ✅ Certificate of Origin (CO) | ✔️ | Critical for de minimis and Section 122 eligibility |
| ✅ FDA 510(k) or CE Mark (if applicable) | ✔️ | Required for medical device classification — not required for reagents, but helpful |
| ✅ Lab Test Reports (e.g., Lot Testing) | ✔️ | Prevents rejection due to quality concerns |
✅ 2.申报技巧 (申报口诀)
🔥 “名称精准,成分明确,试剂归类,税率不跳!”
| Scenario | Correct HS Code | Common Mistake |
|---|---|---|
| Kit contains SARS-CoV-2, Flu A/B, RSV antigens | 3822.19.00.30 |
Misreported as 3002.15.00.91 → no penalty, but less accurate |
| Kit used for antigen detection but no antigens in it | 3002.15.00.91 |
Misreported as 3822.19.00.30 → risk of audit |
| General immunological reagent (e.g., adjuvant, buffer) | 3002.14.00.90 |
Misreported as 3822.19.00.30 → incorrect classification |
✅ Best Practice:
Use exact product name in invoice:“Multiplex Antigen Detection Kit (SARS-CoV-2, Influenza A/B, RSV), Lateral Flow Immunoassay, for In Vitro Diagnostic Use, 25 Tests/Kit”
✅ 3. Special Cases & Solutions
| Situation | Recommended Action |
|---|---|
| Kit contains no antigens, only antibodies | Use 3002.15.00.91 — still qualifies as immunological product |
| Kit is for research use only (RUO) | Still subject to 10% tariff — no exemption |
| Kit is shipped from Vietnam or India | Check CO — if from non-NME country, Section 122 does NOT apply → 0% tariff |
| Value ≤ 5% of shipment (de minimis) | Duty-free entry — no need to pay 10% |
| Multiple kits in one shipment | Consolidate under one HS Code — avoid splitting to reduce risk |
🌍 V. Global Market Comparison (2026 Update)
| Country | Recommended HS Code | Tariff | Certification | Notes |
|---|---|---|---|---|
| 🇺🇸 USA | 3822.19.00.30 / 3002.15.00.91 |
10% (if from NME) | FDA 510(k), CE | Section 122 applies |
| 🇨🇳 China | 3822.19.00.30 |
5% | NMPA | No Section 122 |
| 🇪🇺 EU | 3822.19.00.30 |
0% (if CE) | CE Mark | No extra duties |
| 🇦🇺 Australia | 3822.19.00.30 |
5% | TGA | No Section 122 |
| 🇯🇵 Japan | 3822.19.00.30 |
0% | PMDA | No extra duties |
📌 Insight:
- Only the U.S. applies Section 122 Clause to diagnostic reagents. - Vietnam, India, Mexico, Thailand — if origin is non-NME, 0% tariff applies.
📌 VI. Common Mistakes & How to Avoid Them (Real-World Risks)
❌ Mistake 1: Reporting as “medical device” instead of “reagent”
👉 Result: Wrong HS Code → penalties, delays, reclassification
❌ Mistake 2: Using “antibody kit” instead of “antigen detection kit”
👉 Result: Misleading description → customs suspicion
❌ Mistake 3: Not declaring antigen content
👉 Result: If kit contains antigens, must use 3822.19.00.30 — failure → duty underpayment
❌ Mistake 4: Splitting shipment to avoid de minimis
👉 Result: All items subject to 10% — worse than consolidated
✅ Correct Approach:
“Multiplex Antigen Detection Kit (SARS-CoV-2, Influenza A/B, RSV), Lateral Flow Assay, 25 Tests, Contains Antigens, For In Vitro Diagnostic Use, FDA-Registered, CE Marked”
🎯 VII. Final Summary: Get It Right the First Time
🎯 Key Takeaways:
🔹 3822.19.00.30 = Best fit if antigens are in the kit
🔹 3002.15.00.91 = Best fit if used for antigen detection (even without antigens)
🔹 3002.14.00.90 = Catch-all for other immunological reagents
🔹 All subject to 10% Section 122 Clause (if from NME country)
🔹 De Minimis (5%) applies — duty-free if value ≤ 5%
🔹 No USITC or IEEPA surcharges — only 10% (much better than 25%+)
📣 Action Now: Secure Your Export Success!
📞 Contact a Customs Broker + Provide:
- Product photos
- Certificate of Origin
- Test kit specifications
- Request HS Code Pre-Ruling (Advance Ruling)🚀 Pro Tip:
If your kit is produced in Vietnam, India, or Mexico, apply for CO — you may qualify for 0% tariff!
✨ Your Product. Your Precision. Your Profit.
💼 Accurate HS Code = Smooth Clearance = Lower Cost = Faster Time-to-Market!
✅ Final Quote:
“In diagnostics, the smallest detail — the antigen — determines the entire tariff. Get it right, and your kit clears fast. Get it wrong, and your shipment stalls.”
📌 Pro Tip:
Use “Section 122 Clause” in your invoice notes to flag the 10% tariff — avoids confusion at customs.
📬 Need Help?
📧 Email: [email protected]
🌐 Website: www.yourdiagnostics.com/customs
🚀 Your Multiplex Kit is Ready to Go — Let’s Get It Across the Border!
Customer Reviews
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.