CLA-2-90:OT:RR:NC:N1:105
Adonia Muneno 10X Genomics Inc. 5500 Stoneridge Mall Road Pleasanton, CA 94588
RE: The tariff classification of the Xenium Analyzer from Singapore
Dear Ms. Muneno:
In your letter dated June 20, 2024, you requested a tariff classification ruling.
The item under consideration is described as the Xenium Analyzer, which is a high-resolution, imaging-based spatial profiling technology that allows for simultaneous expression analysis of ribonucleic acid (RNA) targets within the same tissue section. The assay can identify the location of target transcripts within the tissue, providing a single cell resolution map of expression patterns of all genes that are included in the selected probe panel. Researchers can choose between off-the-shelf panels of genes designed to identify cell types and interrogate specific phenotypes, add on 50-gene or 100-gene panels to these off-the-shelf panels, or design a full custom standalone panel to specifically tailor their tissue and research questions.
The current version of the assay uses DAPI (4′, 6-diamidino-2-phenylindole) nuclear stain as the tissue morphology marker to inform on platform segmentation of individual cell borders, but data can be re-processed using third-party segmentation tools. The number of targets is currently limited to approximately 500 genes, though future panels will allow for 1000-plex or 5000-plex and will also allow simultaneous profiling of protein expression targets. Data is viewable with provided desktop tools, and compatible with an array of downstream third-party analysis tools. The Xenium Analyzer starts with Formalin-Fixed Paraffin-Embedded (FFPE) or fresh frozen sections on specific Xenium slides. The section tissue is processed and selected probes hybridized to the RNA targets within the tissue. Bound probes are ligated, forming a circular template that allows rolling circle amplification of the probe and a unique barcode. On the Xenium platform, the tissue with amplified probe products is sequenced through a series of cycles and onboard image data processing that allow identification and location of each transcript target. Resulting data is immediately viewable and is compatible with an easy-to-use data viewer and with many third-party downstream analysis tools. The device measures 52.5 inches by 27 inches by 31 inches. In your letter, you suggest the applicable subheading for the Xenium Analyzer to be 9027.50.4060, Harmonized Tariff Schedule of the United States (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: Other.” While we agree that the Xenium Analyzer is an electrically driven optical test instrument, we find that the device uses a chemical means to perform the analysis. Therefore, there is a subheading earlier in the heading that is more appropriate to how the Xenium Analyzer operates.
Accordingly, the applicable subheading for the Xenium Analyzer 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.
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