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NY J88062




September 4, 2003

CLA-2-84:RR:NC:1:104 J88062

CATEGORY: CLASSIFICATION

TARIFF NO.: 8421.19.9000

Mr. Zainab Nasser
EGL Global Logistics
55 Johnson Road
Lawrence, NY 11559

RE: The tariff classification of a cell washer from Switzerland

Dear Mr. Nasser:

In your letter dated August 13, 2003 on behalf of Helmer Labs, Inc. of Noblesville, Indiana you requested a tariff classification ruling.

Literature, an operations manual and a description from the Technical Manual of the American Association of Blood Banks (14th Ed.) has been provided for the Ultra CW cell washer. The latter document states that a properly functioning cell washer must add large volumes of saline to each tube, resuspend the cells, centrifuge them adequately to avoid excessive red cell loss, and decant the saline to leave a dry cell button. Another document which you have identified as an FDA classification describes an automated cell-washing centrifuge for immuno-hematology.

The Ultra CW, which is used in hospitals, blood banks and diagnostic laboratories, is a countertop unit which weighs 51.5 lbs and has a width of 13”, a depth of 15.5” and a height of 11” with the lid closed and 22.5” with the lid open. It runs on a brushless, variable speed electric motor. The unit is touch-pad controlled and fully programmable. Up to four wash cycles, saline volume, spin time and rpm (up to 3,500) are all user selectable. Other features include a 12 place rotor with an option for a 24 place rotor and a saline flow meter. The Ultra CW is essentially a centrifuge.

You indicate that you received a non-binding advisory opinion from CBP in Cleveland that the cell washer should be classified under HTS subheading 9018.90.80 which provides for instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing apparatus : other: other: other. You also cite the Explanatory Notes to heading 9018 which describes “(x) diagnostic apparatus incorporating or operating in conjunction with an automatic data processing machine” on page 1808 in support of classification under 9018.90.80.

The Harmonized System Explanatory Notes to 9018 indicate that it is for instruments and appliances that are used in professional practice by doctors, nurses, etc. in their direct care and/or diagnosis of an individual patient, which is not the case here. Further, HS EN (I) - (11) to heading 8421 on page 1443 includes “Centrifuges for separating the plasma from blood” in that heading, not in 9018. Also, HS EN exclusion (o) to heading 9018 excludes, “Instruments and appliances used in laboratories to test blood, tissue fluids, urine, etc., whether or not such tests serve in diagnosis ” The fact that your item is registered as a medical device with the Food and Drug Administration does not mandate classification in 9018 since the FDA administers devices to protect the public, not to classify for HTS purposes.

The applicable subheading for the Ultra CW Cell Washer will be 8421.19.9000, Harmonized Tariff Schedule of the United States (HTS), which provides for centrifuges, including centrifugal dryers: other: other. The rate of duty will be 1.3 percent.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Robert Losche at 646-733-3011.

Sincerely,

Robert B. Swierupski
Director,

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