CLA-2-38:OT:RR:NC:N3:135
John Park
WHL Customs Broker Services Inc.
1520 W. Artesia Square
Gardena, CA 90248
RE: The tariff classification of a forensic-use fentanyl detection device from China
Dear Mr. Park:
In your letter dated April 15, 2025, you requested a tariff classification ruling on behalf of Defense
Diagnostics Inc. DBA Defent. Additional information was provided via email on April 24, 2025 and May 9,
2025.
DEFENT ONE is a forensic-use detection device that helps to detect trace amounts of fentanyl in a
substance. It is in the form of immunoassay fentanyl detection strips housed in an all-in one unit. The
single-use device features a a pre-loaded immunoassay test strip, an integrated scoop, distilled water, and a
plastic outer shell. The test strip consists of a wicking pad, a control line, a test line, nitrocellulose membrane,
a conjugate pad, a sample pad, and backing. The control line contains goat anti-mouse antibody. The test line
contains recombinant target antigen. An Au-line contains anti-fentanyl antibody. The line is located on
the test strip’s nitrocellulose membrane, specifically in the test line region. This is where the anti-fentanyl
antibody conjugated to colloidal gold particles is immobilized. When the sample flows through the strip, the
presence of fentanyl is indicated by interaction at this line.
In use, the sample (crushed pill/powder ) is placed in the provided bag, shaken to distribute particles, inserted
into the device, and shaken to thoroughly mix the test sample with pre-measured water. The user removes the
pin and pushes the base of the device up which releases the water and allows the liquid sample to travel
vertically up the immunoassay test strip containing monoclonal antibodies that are specific to fentanyl and its
analogs. The labeled antibodies bind to the target and the sample passes over a conjugate zone that contains
antibodies labeled with color-changing particles (usually gold nanoparticles). If fentanyl (or its analogs) are
present, they bind to the the free antibodies preventing them from binding at the test line(no test line=
positive). If no fentanyl is present, the antibodies bind to the immobilized recombinant antigen, which
represents a portion of the fentanyl molecule, at the test line (note the device does not contain any fentanyl
molecules).
The applicable subheading for the forensic-use fentanyl detection device will be 3822.19.0030, Harmonized
Tariff Schedule of the United States (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; certified reference materials: [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: [c]ontaining antigens or antisera: [o]ther.” The general rate of duty will be
free.
Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and
Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings
9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate
of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition
to subheading 3822.19.0030, HTSUS, listed above.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise
must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of
the Chapter 99 provisions covering exceptions to the reciprocal tariffs. Products of China, including Hong
Kong and Macau, will be assessed an additional ad valorem rate of duty of 125 percent. Products from all
other countries will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you
must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.63, in addition to
subheading 3822.19.0030, HTSUS, listed above.
This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which
are administered by the U.S. Environmental Protection Agency (EPA). Information on the TSCA can be
obtained by contacting the EPA at Document Control Office (7407M), Office of Pollution Prevention and
Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C.,
20460, by calling the Toxic Substances Control Act Hotline at 800-471-7127, by e-mailing to
[email protected], or by visiting their website at www.epa.gov.
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 Fei Chen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division