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April 5, 1996

HQ 955454


CLA-2 RR:TC:FC 955454 ASM

CATEGORY: CLASSIFICATION

TARIFF NO.: 3002.10.0090

Mr. John Cantwell
A.N. Deringer, Inc.
P.O. Box 43
Rte. 37
Massena, NY 13662

RE: Request for tariff classification of the "Gluten Home Test Kit"

Dear Mr. Cantwell:

This letter is in response to your request for a tariff classification of a product known as the "Gluten Home Test Kit" which has been imported into the United States.

FACTS:

The product under consideration is an in-vitro, diagnostic kit, namely: the "Gluten Home Test Kit." According to the descriptive literature supplied, this kit is used to determine the presence of gluten, which is a mixture of many proteins found in wheat, and also, to some extent, in other cereal grains. The need for measuring gluten in foods becomes relevant for individuals afflicted with "Coeliac" disease (the inability to digest gluten). Each kit determines the presence of gluten in foods, based on the principle of a monoclonal antibody-based enzyme immunoassay. The product is a diagnostic kit which is meant to be sold at a retail level, not intended to be administered to a patient.

ISSUE:

Whether the "Gluten Home Test Kit" is properly classified as an "Antisera and other blood fractions" under subheading 3002.10.0050, Harmonized Tariff Schedule of the United States Annotated (HTSUSA), based on the presence of a monoclonal antibody-based enzyme immunoassay.

LAW AND ANALYSIS:

Classification of merchandise under the HTSUSA, is made in accordance with the General Rules of Interpretation (GRI's). The systematic detail of the harmonized system is such that virtually all goods are classified by application of GRI 1, that is, according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI's may then be applied. The Explanatory Notes to the Harmonized Commodity Description and Coding System (EN's), which represent the official interpretation of the tariff at the international level, facilitate classification under the HTSUSA by offering guidance in understanding the scope of the headings and GRI's.

The main component of the product is the monoclonal antibody. Antibodies are immunoglobulins which are stimulated by an antigenic response. Monoclonal antibodies are highly specific antibodies produced by hybridoma cells. The kit is composed of gluten standards for quantitative evaluation, an extractant solution, a stopping solution, washing buffer, diluent buffer, and the anticlonal antibodies (immobilized on microwell strips). Additionally, the extractant solution contains additives which serve as binders for the ployphenols, which are known to interfere in the extraction of gliadins.

Although the kit's main component is the monoclonal antibody, the kit contains other elements which make it a "composite" diagnostic reagent. Nevertheless, the product is not classifiable as a composite diagnostic reagent under heading 3006, HTSUSA, because it is intended as a self-diagnostic kit sold at the retail level and is not necessarily intended to be administered to a patient.

GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, accordiang to the remaining GRI's taken in order. Inasmuch as the kit contains items that may be classified under more than one heading (i.e., monoclonal antibodies, gliadin antigen reference standard, starch reference standards, and binders for polyphenols in the extraction solution), it is not classifiable pursuant to GRI 1. GRI 2 is inapplicable because it governs the classification of incomplete or unfinished articles or mixtures, neither of which apply to this product. Classification under GRI 3(a) is not applicable because there is no single heading which provides the most specific description for the kit.

GRI 3(b) is applicable when goods are, prima facie, classifiable under two or more headings, and have been put up in sets for retail sale. GRI 3(b) states that the goods "shall be classified as if they consisted of the material or component which gives them their essential character." In this case, the kit constitutes "goods put up in sets for retail sale." The main component of the product, which provides for the essential character of the kit, is the monoclonal antibody. The classification, therefore, is governed by GRI 3(b), with the essential character of each kit imparted by the monoclonal antibody component.

It is our position that this set or kit, having the monoclonal antibodies as its essential character is properly classifiable in subheading 3002.10.0090, HTSUSA, which provides for "Antisera and other blood fractions and immunological products." Furthermore, the 1996 HTSUSA now specifically provides for monoclonal antibodies in Chapter 30, Note 2, which states as follows:

For the purposes of heading 3002, the expression "modified immunological products: applies only to monoclonal antibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates.
.

In addition, the ENs to heading 3002 states that the heading covers "Antisera... used for diagnostic purposes, including in vitro tests. Specific immunoglobulins are purified preparations of antisera." Clearly this heading covers the subject kit because, as previously mentioned, the kit is intended to be self-administered for a diagnostic purpose and contains as its primary component the monoclonal antibody which is an immunoglobulin that will be stimulated by an antigenic response.

HOLDING:

The product identified under the name, "Gluten Home Test Kit," is properly classifiable within subheading 3002.10.0090, HTSUSA, which provides for "Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; anitsera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; Other." Merchandise classified under the foregoing subheading is duty free in column one.

Although your original request referenced a second product, "Gluten Lab Test Kit," we have been unable to provide a ruling on this item because there was no record of a sample being received or tested by the U.S. Customs Service.

This merchandise may be subject to the regulations of the Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, MD 20857, telephone number (301) 443- 3170.

Sincerely,

John Durant, Director

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