38221900
MISCELLANEOUS CHEMICAL PRODUCTS›Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits, other than those of heading 3006; certified reference materials
Other
Tariff classification
CN code 382219 covers other diagnostic and laboratory reagents, not elsewhere specified, other than reagents on a backing or in kit form. These products include chemical reagents used in laboratory analyses, quality control, clinical diagnostics, and scientific research. Classification requires the product to be a reagent intended for diagnostic or analytical purposes rather than a raw chemical substance classified in Chapters 28 or 29.
IVD, REACH and CLP regulations
Diagnostic reagents intended for in vitro diagnostics are subject to Regulation (EU) 2017/746 on IVD devices and may require CE marking. Research-use reagents are subject to REACH and CLP. SDS is required. Reagents containing hazardous substances must be correctly labelled per CLP. The importer must ensure compliance with regulatory requirements appropriate for the declared product use.
Import and trade
The customs declaration under CN code 382219 should include trade name, composition, intended use, and product form. Customs authorities may require documentation confirming classification as a diagnostic reagent. Duty rates are checked in TARIC. IVD diagnostic reagents may be subject to duty exemption under special provisions.
Other IVD reagents - risk classification
Other diagnostic reagents under CN 3822 19 cover IVD reagents not specified elsewhere: immunological, molecular and haematological tests. Subject to IVDR risk classification (classes A-D) with corresponding conformity assessment procedures. Importers should ensure correct tariff classification in the TARIC system and present complete customs documentation. Customs authorities verify product compliance with the declared CN code and collect applicable duties and import VAT.
Frequently asked questions
When does a reagent require CE marking as an IVD device?
A reagent requires CE marking when intended by the manufacturer for in vitro diagnostics, i.e., for examining specimens from the human body to obtain information on physiological or pathological state. Research-only reagents do not require CE marking.
Are laboratory reagents subject to REACH?
Yes, laboratory reagents are subject to REACH. However, substances and mixtures used for research and development purposes in quantities below one tonne per year may benefit from registration exemption under Article 9 of REACH.
What documents are required for diagnostic reagent import?
Required are SDS, commercial invoice, REACH documentation, and for IVD devices additionally EU declaration of conformity, CE certificate, and technical documentation. Customs may request confirmation of the product's diagnostic or research purpose.
How are reagents CN 3822 19 classified under IVDR?
Reagents CN 3822 19 are classified under IVDR into Class A (low risk), B (blood group tests), C (HIV/HCV tests) or D (highest risk). The risk class determines the conformity assessment level.
Useful tools & resources
Customs calculators
Related glossary terms