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HQ 087874

January 4, 1991

CLA-2 CO:R:C:G 087874 AJS


TARIFF NO.: 3822.00.10

Ms. Mary Pat Funk
Marketing Associate
Meridian Diagnostics, Inc.
3471 River Hills Drive
Cincinnati, OH 45244

RE: Serofast in vitro diagnostic kit; Heading 3002; Explanatory Note 3002; antisera; Subheading 3822.00; Subheading 3822.00.10; reagent; antigen.

Dear Ms. Funk:

Your letter of September 4, 1990, requesting a tariff classification regarding the Serofast kit has been forwarded to this office for reply.


The merchandise at issue is the Serofast in vitro diagnostic test kit. This kit is composed of a latex reagent (polystyrene beads coated with an antigen and a buffer), a positive control reagent (containing an antibody and a buffer), a negative control reagent (rabbit serum without antibodies and a buffer), a dilution buffer (containing bovine serum albumin, NaCl, glycin, sodium azide and a PH adjuster), a test slide and pipestirs. The kit will be used in the detection and titration of antibodies anti mycoplasma pneumoniae in human blood serum.


What is the proper tariff classification of the Serofast kit within the Harmonized Tariff Schedule of the United States Annotated (HTSUSA).


Classification of merchandise under the HTSUSA is governed by the General Rules of Interpretation (GRI's). GRI 1 provides that classification is determined first in accordance with the terms of the headings of the tariff and any relative section or chapter notes.

Heading 3002, HTSUSA, provides for antisera and other blood fractions. Antisera are obtained from the blood of animals which are immune or have been immunized against diseases or ailments. Explanatory Note (EN) 30.02. They are also used for diagnostic purposes, including in vitro tests. EN 30.02. The subject kit is composed of a reagent containing rabbit serum and a buffer containing bovine serum. These items satisfy the terms of this heading. However, the kit is also composed of reagents which do not satisfy the terms of this heading. Accordingly, the kit as a composite cannot be classified within this heading by application of GRI 1.

Subheading 3822.00, HTSUSA, provides for composite diagnostic or laboratory reagents, other than those of heading 3002 or 3006. The subject kit satisfies the terms of this subheading. It is composed of latex, positive control and negative control reagents which are used in the clinical laboratories of hospitals for diagnostic purposes. As stated previously, the kit as a composite is not composed of reagents from heading 3002, HTSUSA. The subject kit also does not satisfy the terms of heading 3006, HTSUSA, which provides for various pharmaceutical goods. Subheading 3822.00.10, HTSUSA, provides for composite reagents which contain antigens or antisera. The subject kit contains both antigen and antisera. Accordingly, the Serofast kit satisfies the terms of this subheading and is classifiable therein.


The Serofast kit in question is properly classifiable within subheading 3822.00.10, HTSUSA, which provides for composite diagnostic or laboratory reagents, other than those of heading 3002 or 3006, which contain antigens or antisera. These articles are entitled to duty-free treatment.


John Durant, Director
Commercial Rulings Division

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