CLA-2-38:OT:RR:NC:N1:135
Ms. Karen L. Prouty
IDEXX Laboratories
One IDEXX Drive
Westbrook ME 04092
RE: The tariff classification of a diagnostic test kit from an undisclosed country
Correction to Ruling Number N298292
Dear Ms. Prouty:
This replaces Ruling Number N298292, dated July 12, 2018, which contained a clerical error. The phrase “HRP antibody” should be changed to “HRP” when describing the six enzyme conjugates. A complete corrected ruling follows.
In your letter dated June 25, 2018, you requested a tariff classification ruling.
SNAP 4DX Plus Test Kit (Product number 99-26193) is described as an enzyme-linked immunosorbent assay veterinary diagnostic test kit. It is a qualitative test for detecting the presence of antigens to Heartworm disease and antibodies to Anaplasma spp., Lyme disease, and Ehrlichia spp. in canine blood samples. The kit consists of a plastic lateral flow device and a vial. The top of the device has a sample well, a result window (reaction area) containing five spots, an activation circle, and an activator. Inside the device, it houses a lateral flow membrane immobilized (spotted) with four specific “reagents” representing four test systems and one control “reagent,” which appear on top as five spots. Three spots are impregnated respectively with specific antigens of Anaplasma, Lyme, and Ehrlichia. The fourth spot contains an antiHeartworm antibody. The fifth spot (control spot) contains a goat antiHorse Radish Peroxidase (HRP) antibody. The control spot serves only as a test validity check, verification that the device is functional. The device also houses a detergent wash (buffer) solution and an enzyme substrate (buffer) solution. The vial contains a liquid mixture of six enzyme conjugates. The first enzyme conjugate is an Anaplasma antigen conjugated to HRP. The second enzyme conjugate is an antiHeartworm antibody conjugated to HRP. The third enzyme conjugate is a Lyme antigen conjugated to HRP. The fourth, fifth and sixth enzyme conjugates in the mixture are three individual Ehrlichia antigen HRP conjugates.
In use, a test sample and the mixture are dispensed into a sample tube and mixed by inversion. The final mixture is then poured into the sample well in the device. When the flow reaches a certain location on the membrane, the flow is reversed washing away unbound reactants and allowing the substrate solution to react with the enzyme conjugates remaining bound to the respective spots. After a set time, the device is read visually or by an instrument reader, and development of a blue color indicates a positive result.
The applicable subheading for the SNAP 4DX Plus Test Kit will be 3822.00.1090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Diagnostic or laboratory reagents on a backing and prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002 or 3006: Containing antigens or antisera: Other.” 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 merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
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