&&The good in issue is a plastic cup with a screw top lid containing diagnostic test strips on paper backings attached to the inside of the cup. The reagents on the test strips react with the urine sample that is collected in the cup to provide an indication of whether or not up to 12 different drug types are present in the sample. This is done by an immunoassay method based on monoclonal antibodies which screens for specific drugs and their metabolites. The outside sticker on the cup is then peeled off to reveal the results of the test. Each cup also comes in a sealable composite bag made of plastic and aluminum foil.

&&The good in issue is considered a diagnostic kit whose primary function is to test for the presence of specific drugs in a person’s system through a urine sample. Heading 38.22 covers, “Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, other than those of heading 30.02 or 30.06”. However, the Explanatory Notes to the heading state that diagnostic kits having the essential character of products of heading 30.02 or 30.06 (e.g., those based on monoclonal or polyclonal antibodies) are excluded.&& &&&&Heading 30.02 includes immunological products. The Explanatory Note to heading 30.02 states, “Diagnostic kits are classified here when the essential character of the kit is given by any of the products of this heading. Common reactions occurring in the use of such kits include agglutination, precipitation, neutralization, binding of complement, haemagglutination, enzyme-linked immunosorbent assay (ELISA), etc. Malaria diagnostic kits based on monoclonal antibodies to PLDH (plasmodium lactate dehydrogenase) are for instance classified here. The essential character is given by that single component which governs to the greatest extent the specificity of the test procedure”. This product is considered a diagnostic kit which uses an immunoassay method with monoclonal antibodies to detect the presence of specific drugs in a sample of urine.&&&&Thus, the good in issue is classified under heading 30.02, specifically subheading 3002.15, as immunological products, put up in measured doses or in forms or packings for retail sale.&&&&