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

Mr. Grégoire Wyss
Lunaphore Technologies SA
Route de Lully 5C Tolochenaz 1131 Switzerland

RE: The tariff classification of a hyper‐plex immunofluorescence system from Germany

Dear Mr. Wyss:

In your letter dated February 22, 2023, you requested a tariff classification ruling.

The item under consideration is the Comet hyper‐plex immunofluorescence system (COMET), which is an automated system designed to perform multiplex fluorescent immunohistology assays. The device provides for visualization of protein expression using antibody binding distributed across the sample. The antibodies used in the system are solely for localization of specific proteins. The Comet is based on microfluidic technology (consumable chip) that delivers staining reagents and buffers in a controlled and timed manner onto a biological tissue sample. Stained samples are then scanned with the integrated microscope for image visualization. Successive rounds of staining, imaging, and elution are performed in a sequential manner to achieve multiplexing. The system is for use in a laboratory setting for research purposes only.

In operation, the system detects the emission of light of a specific wavelength from a fluorophore bound to the sample by exciting it with light of a specific wavelength. In the instrument, a consumable chip is clamped over a standard histological glass slide, forming a closed chamber of reaction over the sample. This creates an ultra-controlled staining environment where reagents are delivered onto the tissue fast and uniformly. It generates digitalized stacks of images from individual rounds of measurement of light signal of specific wavelengths emitted from the sample based on the antibody solutions used.

In your letter, you suggest the applicable subheading for the Comet hyper‐plex immunofluorescence system to be 9027.89.8090, 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: Other: Other: Other: Other.” We disagree. The Comet is an electrical device that detects the emission of light of a specific wavelength from a fluorophore bound to a sample by exciting it with light of a specific wavelength. There is a specific subheading earlier in heading 9027, HTSUS, for instruments and apparatus utilizing such optical radiations.

Accordingly, the applicable subheading for the Comet hyper‐plex immunofluorescence system 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/current.

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