CLA-2-90:OT:RR:NC:N1:105

Nick Eroraveno 900 Middlesex Turnpike Billerica, MA 01821

RE: The tariff classification of a bead reader from China

Dear Mr. Eroraveno:

In your letter dated August 12, 2024, on behalf of your client, Quanterix Corporation, you requested a tariff classification ruling. Descriptive literature was provided for our review.

The item under consideration is described as the SimoaOne Bead Reader, which is an instrument that utilizes flow cytometry-based principles to measure biomarkers. The consumables used with this reader are ultra sensitivity immunoassay kits. Using the kits, the user tags the particles being measured with fluorescence markers. On the instrument, the particles on the beads tagged with fluorescence are then pushed through a flow cell to be individually activated by lasers. The reader then counts on and off beads (on beads means a particle with fluorescence is detected and off beads means no fluorescence is detected). The raw data is captured in a file on the reader, which is then transferred to a computer and analyzed by proprietary software. The software displays AEB (average enzyme per bead) values, which correlates to biomarker concentration in the tested samples. The SimoaOne is utilized in the biotechnology industry, academic laboratories, commercial laboratories (in pharmaceutical and biotechnology companies), and contract research organizations. The device measures 47 cm wide by 44 cm deep by 43 cm high and weighs 30 kg. The device is imported with the reader, instrument documentation (including but not limited to the user manual), and a fluidics accessory kit. General Rule of Interpretation (GRI) 1, Harmonized Tariff Schedule of the United States (HTSUS), states in part that for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes. Goods that are, prima facie, classifiable under two or more headings, are classifiable in accordance with GRI 3, HTSUS. GRI 3(a) states, in part, that when two or more headings each refer to part only of the items in a set put up for retail sale, those headings are to be regarded as equally specific, even if one heading gives a more precise description of the good. The instant good consists of at least two different articles that are, prima facie, classifiable in different subheadings. It consists of articles put up together to carry out a specific activity (i.e., bead analysis). Finally, the articles are put up in a manner suitable for sale directly to users without repacking. Therefore, the good in question is within the term goods put up in sets for retail sale. GRI 3(b) states, in part, that goods put up in sets for retail sale, which cannot be classified by reference to GRI 3(a), are to be classified as if they consisted of the component which gives them their essential character. It is our opinion that the essential character of the kit is imparted by the SimoaOne Bead Reader.

Accordingly, the applicable subheading for the SimoaOne Bead Reader will be 9027.50.4015, HTSUS, which provides for Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared): Other: Electrical: Chemical analysis instruments and apparatus. The general rate of duty will be free. Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9027.50.4015, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 9027.50.4015, HTSUS, listed above. The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china respectively.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.

This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Jason Christie at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division