HS Code for Diagnostic Test Kits
The HS Code for diagnostic test kits is 382200. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 382200 |
|---|---|
| US HTS (10-digit) | 3822000000 |
| EU CN Code (8-digit) | 38220000 |
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 38 |
| Heading | 3822 |
| Last Updated | 2026-05 |
Description
Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents
HS Code 382200 covers diagnostic or laboratory reagents on a backing with a US MFN duty rate of Free.
Frequently Asked Questions
What customs inspection risks are specific to diagnostic test kits classified under HTS 382200?
Diagnostic test kits under HTS 382200 face high scrutiny for misclassification as medical devices (Chapter 90) or pharmaceuticals (Chapter 30). Customs authorities frequently inspect these shipments to verify the product's composition is primarily 'reagents on a backing' and not a functional device, as this determines duty rates and regulatory pathways. Proper documentation, including a detailed product breakdown and intended use statement, is critical to avoid delays and penalties.
What additional duties or fees apply when importing diagnostic test kits under HTS 3822.00?
In addition to the general duty rate, imports of diagnostic test kits under HTS 3822.00 are subject to a Merchandise Processing Fee (MPF) of 0.3464% of the entered value (min. $31.67, max. $634.62). Furthermore, these goods are typically flagged for FDA review, which may incur customs brokerage fees for handling the required Prior Notice submission and other FDA data filings.
Compliance Notes for Diagnostic Test Kits
Test kits used for professional, laboratory, or clinical diagnostic purposes are generally classified under 3822.00. However, kits intended for home use or direct-to-consumer sales may fall under a different chapter (e.g., 3006 or 9018) depending on their presentation and purpose. Many diagnostic kits are subject to regulation and pre-approval by government health agencies like the FDA in the US; proper Harmonized System (HS) classification is often required for this regulatory approval process. Ensure the kit's reagents (often in 3822) and any accompanying instruments (e.g., in 9018 or 9027) are classified separately if not presented together as a single functional unit.
Related HS Codes
Ready to source Diagnostic Test Kits?
Compare prices from verified suppliers on Alibaba.
View Verified SuppliersAffiliate link — we may earn a commission at no extra cost to you.
Related Tools
Get tariff change alerts
We'll email you when duty rates change for products you care about. No spam.