CLA-2-38:OT:RR:NC:N3 135
Patricia Casabona
Genscript USA Inc.
860 Centennial Ave.
Piscataway, NJ 08854
RE: The tariff classification of a His Tag ELISA (Enzyme-Linked Immunosorbent Assay) Detection Kit
from China
Dear Ms. Casabona:
In your letter dated April 24, 2025, you requested a tariff classification ruling.
His Tag ELISA Detection Kit is a competition ELISA (Enzyme-Linked Immunosorbent Assay), developed
for rapid and high throughput detection of His-tagged proteins. The kit is packed for retail sale and contains
the following components: one His Tag Plate (1 plate (8 wells × 12 strips), one vial of Anti-His Monoclonal
Antibody (6 ml), one vail of Antibody Tracer (12 ml), eight vails of His Tag Standards (0,1,3,9,27,81,243,
and 729 ng/ml, 1 ml per each standard), one vial of Assay Diluent (60 ml), one vial of 20 × Wash Solution
(40 ml), one vial of TMB Solution (12 ml), one vial of His Tag Standard Stock (10 µg/ml) (500 µl), and two
Plate Sealers. You state that the kit provides all reagents and solutions required for His-tagged protein
detection.
This kit is based on competitive ELISA method. The His Tag Plate in the kit is a 96-well microtiter plate
coated with a His-tagged protein with the molecular weight of 12.7 kDa. The plate, which comprises of 8
wells × 12 strips, is demountable. When the Anti-His Monoclonal Antibody and His-tagged proteins are
added to the well, the coated His-tagged proteins compete with the His Tag Standard in solution or the
His-tagged protein in sample to interact with the Anti-His Monoclonal Antibody. The higher the
concentration of the His-tagged protein in solution is, the less the antibody bound to the plate will be. The
Anti-His-tagged Monoclonal Antibody used in the kit is a mouse anti-His tag monoclonal antibody and the
Antibody Tracer, which is a horseradish peroxidase (HRP) conjugated Goat anti mouse igG, is used for
enzyme reaction. The His-tagged protein, Anti-His Monoclonal Antibody, and Antibody Tracer form a
complex. Other unbound molecules can be removed by washing solution. The Antibody Tracer reacts with
the TMB Solution to develop a blue product that turns yellow immediately when the Stop Solution is added,
which can be measured by microplate reader at 450 nm.
In your letter you suggest classification in subheading 3002.15.0091, Harmonized Tariff Schedule of the
United States (HTSUS), which provides for “[a]ntisera, other blood fractions and immunological products,
whether or not obtained by means of biotechnological processes: [i]mmunological products, put up in
measured doses or in forms or packings for retail sale: [o]ther.” The His Tag ELISA Detection Kit is no
longer classified in heading 3002 as a result of changes to the 2022 HTSUS, which directed various
diagnostic kits such as the enzyme-linked immunosorbent assay (ELISA) kits to be classified in heading 382
2, HTSUS.
The applicable subheading for the His Tag ELISA Detection Kit 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;
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: [o]ther:
[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 3822.19.0080, 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. At this time products from all
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. 9903.01.25, in addition
to subheading 3822.19.0080, 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.
The tariffs and additional duties cited above are current as of this ruling’s issuance. 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