Coagulation Function Reagents
CN β US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 3002120090 | 10.0% | CN | US | Official Doc |
| 3002905250 | 10.0% | CN | US | Official Doc |
| 3822190080 | 10.0% | CN | US | Official Doc |
| 3822190030 | 10.0% | CN | US | Official Doc |
| 30069990 | 0.0% | CN | US | Official Doc |
| 38220090 | 0.0% | CN | US | Official Doc |
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AI Analysis
π§ͺ Coagulation Function Reagents (θ‘ζΆ²εεΊεθ½θ―ε)
π HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Entry Strategy
π I. Product Definition & Classification: What Exactly Are "Coagulation Function Reagents"?
Coagulation Function Reagents are specialized chemical or biological preparations used in clinical laboratories to analyze blood clotting factors. They are critical for diagnosing bleeding disorders (like hemophilia), monitoring anticoagulant therapy (e.g., Warfarin, Heparin), and pre-surgical screening.
In international trade, these reagents are classified based on their format and specific composition: * Kits/Form 1 (Heading 3822): Reagents on a backing, prepared kits, or specific diagnostic preparations not primarily based on human/animal blood derivatives. * Kits/Form 2 (Heading 3006): Diagnostic reagents that may be certified reference materials or specific blood fraction-based tests, often falling under medical devices/pharmaceutical precursors. * Blood Fractions (Heading 3002): If the reagent is primarily composed of human/animal blood derivatives (e.g., specific antisera or plasma fractions).
β οΈ Critical Distinction:
- If the product is a commercially packaged kit or prepared reagent on a backing (e.g., slides, strips) for lab use β Look at Heading 3822.
- If the product is a generic chemical preparation not specifically packaged for diagnostics as a primary feature β Look at Heading 3822.00 or 3006.99.
- If the product is derived from blood fractions (antisera, plasma) β Look at Heading 3002.
π¦ II. HS Code Classification Details (2026 Authoritative Mapping)
Based on the provided data, here are the relevant HS Codes and their tax implications:
| HS Code | Product Description | Applicability | Contains Antigens/Antisera? |
|---|---|---|---|
| 3822.19.00.80 | Diagnostic or laboratory reagents on a backing, prepared reagents, or kits (Other) | General diagnostic kits, reagent strips, non-specific coagulation reagents | β No (General) |
| 3822.19.00.30 | Diagnostic/laboratory reagents containing antigens or antisera | Reagents derived from blood fractions or specific immunological reactions | β Yes (Specific) |
| 3006.99.90 | Other diagnostic/laboratory reagents, including coagulation function testing (Error in Tax Retrieval) | Specific coagulation test kits not covered under 3822 | β οΈ Tax Info Error |
| 3822.00.90 | Other chemical products and preparations, including reagents for lab/diagnostic use (e.g., coagulation) | Generic chemical reagents not specifically "on a backing" or "kits" | β οΈ Tax Info Error |
| 3002.12.00.90 | Antisera, other blood fractions, immunological products (Other) | Reagents primarily made from human/animal blood fractions | β Yes (Blood-derived) |
| 3002.90.52.50 | Human/animal blood prepared for diagnostic uses; other blood fractions (Other) | Blood-based diagnostic preparations | β Yes (Blood-based) |
π Key Insight:
- 3822 is the most common heading for standard coagulation kits (e.g., PT/APTT reagents).
- 3002 applies only if the reagent is biologically derived from blood (antisera/fractions).
- 3006.99.90 and 3822.00.90 appear in the data with "Failed to retrieve tax information". This indicates potential classification ambiguity or missing tariff data in the source system. Extreme caution is advised for these codes.
π° III. 2026 Tariff Rate Breakdown (Detailed Analysis)
β Applicable Market: General (Based on provided tax details)
β Origin: Not specified, but tax details suggest standard imports (likely US/China trade context given the format)
β Note: The data provided shows 0% tax for specific 3822/3002 codes, but Error for others.
π― 1. 3822.19.00.80 & 3822.19.00.30 ββ Diagnostic Reagents (Kits/Backings)
| Item | Content |
|---|---|
| Base Duty Rate | 0.0% (ad valorem) |
| Additional Duty | 0.0% |
| Total Effective Tax | 0.0% |
| Tax Detail | εΊη‘ε
³η¨: 0.0%, ε εΎε
³η¨: 0.0% |
| Legal Basis | Standard HS classification for prepared diagnostic reagents |
π Explanation:
- Most standard coagulation reagent kits (e.g., PT, APTT, INR strips) fall under 3822.19.00.80 or 3822.19.00.30 if they contain antigens/antisera.
- The provided data explicitly states 0% total tax for these codes. This is highly favorable.
- 3822.19.00.30 is for reagents containing antigens or antisera. If your coagulation test uses immunological methods (e.g., antigen-antibody reaction), use this code.
- 3822.19.00.80 is for other diagnostic reagents (e.g., enzymatic coagulation tests).
π― 2. 3002.12.00.90 & 3002.90.52.50 ββ Blood Fractions/Antisera
| Item | Content |
|---|---|
| Base Duty Rate | 0.0% (ad valorem) |
| Additional Duty | 0.0% |
| Total Effective Tax | 0.0% |
| Tax Detail | εΊη‘ε
³η¨: 0.0%, ε εΎε
³η¨: 0.0% |
| Legal Basis | Medical/Biological products derived from blood |
π Explanation:
- If your reagent is purely a blood fraction (e.g., specific human plasma for coagulation factor testing), it may fall under 3002.
- The data shows 0% tax for these codes as well.
- Note: These are biological products and may require additional FDA/EMA approvals for import, even if tax is 0%.
π¨ 3. 3006.99.90 & 3822.00.90 ββ β οΈ Tax Retrieval Error
| Item | Content |
|---|---|
| Tax Status | ERROR |
| Tax Detail | Failed to retrieve tax information |
| Total Tax | Error |
π CRITICAL WARNING:
- Do not use these codes without verification.
-3006.99.90and3822.00.90are likely fallback categories. If your reagent doesn't fit neatly into "kits" (3822.19) or "blood fractions" (3002), it might land here.
- Risk: "Failed to retrieve" implies the system cannot confirm the tax rate. It could be 0%, 5%, 10%, or even 25%.
- Action: Request a Pre-Ruling or consult a customs broker to confirm the actual duty for these specific codes. Misclassification here can lead to significant unexpected duties or customs detention.
π οΈ IV. Customs Clearance Practical Advice (Avoid Pitfalls)
β 1. Documentation Checklist (Must-Haves)
| Document | Required? | Purpose |
|---|---|---|
| Product Specification Sheet | β Yes | Details ingredients, method of test (enzymatic vs. immunological), and intended use. |
| Label Images | β Yes | Must show "For In Vitro Diagnostic Use" and "Do Not Use in Humans" (if applicable). |
| CoA (Certificate of Analysis) | β Yes | Proves purity and composition, especially for blood-derived products. |
| Commercial Invoice | β Yes | Clearly describe as "Coagulation Function Reagents, For Laboratory Use Only". |
| FDA/CE Approval Docs | β Yes | If importing to US/EU, regulatory approval is mandatory regardless of tax. |
| MSDS/SDS | β Yes | Chemical safety data sheet, especially if reagents contain hazardous chemicals. |
β 2. Classification Strategy (Key Rules)
π₯ "Kit vs. Chemical: The 3822 Rule"
| Scenario | Correct HS Code | Reason |
|---|---|---|
| Pre-packaged kit with multiple reagents for a single test (e.g., PT Reagent + Control) | 3822.19.00.80 or 3822.19.00.30 | It's a "kit" or "prepared reagent." |
| Reagent on a backing (e.g., test strips) | 3822.19.00.80 | Specifically "on a backing." |
| Reagent containing antigens/antisera (immunological) | 3822.19.00.30 | Specific subheading for immunological reagents. |
| Pure blood fraction (e.g., plasma) | 3002.12.00.90 or 3002.90.52.50 | Biological origin. |
| Generic chemical solution (not a kit, not on backing) | 3822.00.90 or 3006.99.90 | β οΈ High Risk β Verify tax! |
β 3. Special Cases & Warnings
| Case | Advice |
|---|---|
| Reagents with Biological Components | Even if tax is 0%, biological products require health authority clearance (e.g., FDA 510(k) in the US). Do not assume "0% tax" means "easy entry." |
| Misclassification Risk | Using 3006.99.90 or 3822.00.90 without confirmation can lead to 2-5 year audits if the tax is later determined to be higher. |
| Kits with Mixed Components | If a kit includes a device (e.g., a coagulometer) and reagents, the device may be classified separately (e.g., 9018/9027). Consult a broker for complex kits. |
| Labeling Compliance | Ensure labels state "For In Vitro Diagnostic Use" to avoid classification as a pharmaceutical (which has different tax/regulatory regimes). |
π V. Global Market Comparison (2026 Overview)
| Market | Recommended HS Code | Tax Rate | Key Regulatory Requirement |
|---|---|---|---|
| πΊπΈ USA | 3822.19.00.80 / 3002.12.00.90 |
0% (per data) | FDA 510(k) or De Novo; ELISA/PCR certification if applicable. |
| π¨π³ China | 3822.19.00.80 |
Varies (Check Local Tariff) | NMPA Registration; IVD License. |
| πͺπΊ EU | 3822.19.00.80 |
Varies (Check Local Tariff) | CE Marking (IVDR Regulation); RoHS. |
| π¬π§ UK | 3822.19.00.80 |
Varies | UKCA Marking; MHRA approval. |
π Conclusion:
- The US appears to offer 0% duty for standard diagnostic reagents under 3822 and 3002 based on the provided data.
- However, regulatory barriers (FDA) are the primary challenge, not tariffs.
- Avoid 3006.99.90 and 3822.00.90 unless you have confirmed the tax rate.
π VI. Common Mistakes & Pitfalls (Lessons Learned)
β Mistake 1: Classifying a coagulation kit under 3006.99.90
π Consequence: Tax retrieval error β Potential delay in customs release and additional fees.
π Fix: Use 3822.19.00.80 (if not containing antigens) or 3822.19.00.30 (if containing antigens).
β Mistake 2: Labeling reagents as "Laboratory Chemicals" instead of "Diagnostic Reagents"
π Consequence: Misclassification β Possible higher tax or regulatory violation.
π Fix: Clearly state "For In Vitro Diagnostic Use" on all documentation.
β Mistake 3: Assuming 3002.12.00.90 applies to all blood-related tests
π Consequence: If the reagent is synthetic or enzymatic (not blood-derived), it should be 3822.
π Fix: Verify the origin of the active ingredient (synthetic vs. blood-derived).
π― VII. Conclusion: Precision in Classification, Efficiency in Clearance
π― Key Takeaway:
πΉ "Diagnosing Reagents: 3822 is King, 3002 is for Blood, 3006/3822.00 is Risky!"
πΉ "Tax is 0%, but Regulation is 100%!"
β
Final Recommendation:
1. Classify under 3822.19.00.80 or 3822.19.00.30 for standard diagnostic kits.
2. Classify under 3002.12.00.90 only for blood-derived antisera/fractions.
3. Avoid 3006.99.90 and 3822.00.90 unless you have confirmed the tax rate.
4. Secure FDA/CE approval before shipping, regardless of tax rate.
π£ Immediate Action:
π Contact a Customs Broker to verify the 3006.99.90 and 3822.00.90 tax rates.
π Ensure all labels comply with IVD regulations.
π Ship with confidence using 3822.19.00.80 or 3822.19.00.30 for standard reagents!
β¨ Professional Classification Saves Time and Money!
πΌ Your Reagents, Your Compliance, Your Success!
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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) β Broad category of goods (e.g., Chapter 84: Machinery and Mechanical Appliances)
- Heading (4 digits) β More specific grouping within the chapter
- Subheading (6 digits) β Internationally standardized breakdown, used by all WCO member countries
- National subdivisions (8-10 digits) β 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 β The standard duty rate applied to WTO members
- General rate β Applied to countries without trade agreements
- Trade remedy duties β 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.