CLA-2-38:OT:RR:NC:N3:135

Mr. Thomas Hartner
DOTS Technology Corp.
16 Tech Circle
Natick, MA 01760

RE: The tariff classification of Single-Use Pods from Mexico

Dear Mr. Hartner:

In your letter dated February 22, 2022, you requested a tariff classification ruling.

This ruling request was submitted because the tariff number for the Single-Use Pods ruled in NY ruling N317234 dated February 5, 2021 has been changed at the subheading level in the 2022 version of the Harmonized Tariff Schedule of the United States (HTSUS). You state you have moved manufacturing of the Pods from China to Mexico, but there are no changes in product design or functionality.

The DOTS’ single-use pod consists of a stadium-shaped plastic base and top, a fluidics panel, a rotor, and other components and is filled with Signaling Polynucleotides (SPN) and a buffer solution. The fluidics panel component contains the assay that binds the active molecule, which detects the presence of the allergen protein. The chemical reaction between the SPN and assay yields a detectable signal indicating the presence of the target allergen. In use, the pod is inserted into the food allergen device. The pod’s rotor “blends” a cut food sample and releases protein from the food. The protein is then mixed with the SPN and buffer. When the SPN is bound to the assay via DNA: DNA interactions, a signal is produced that indicates the absence of the allergen protein in the protein extracted from the food sample. If the allergen protein is present in the protein extracted from the food sample, the binding interaction does not occur and no signal is produced. The user is alerted to the test results on the device.

The applicable subheading for the Single-Use Pods will be 3822.19.0080, HTSUS, which provides for “[d]iagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits, other than those of heading 3006 ... [d]iagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits: [o]ther: [o]ther: [o]ther.” 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 on World Wide Web at https://hts.usitc.gov/current.

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 Fei Chen at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division