3002.13.00 - Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale

This HTS classification, 3002.13.00, encompasses immunological products that are unmixed and not presented in measured doses or in forms or packings suitable for retail sale. These are specific biological preparations designed to elicit an immune response or provide passive immunity, but they are in a bulk or intermediate form, rather than ready for direct administration to patients or consumers. The key differentiating factor here is the absence of pre-determined dosage units or final retail packaging.

Distinguishing this category from its siblings, 3002.12.00 covers antisera and other blood fractions, which are broader categories. Unlike 3002.14.00, which deals with *mixed* immunological products, this heading specifically addresses *unmixed* formulations. Furthermore, it is separate from 3002.15.00, which designates immunological products that *are* packaged for retail or in measured doses. Therefore, 3002.13.00 serves as a distinct classification for intermediate immunological products not yet prepared for end-use or direct sale.

The subcategories within 3002.13.00 further refine the classification of these unmixed immunological products. 3002.13.00.10 specifically captures monoclonal antibodies, a significant class of immunological products used in diagnostics and therapeutics. The residual category, 3002.13.00.90, covers all other unmixed immunological products that do not fall under the monoclonal antibody designation, ensuring comprehensive coverage within this intermediate stage of immunological product preparation.