CLA-2-38:OT:RR:NC:2:239
Deborah Stern
Sandler, Travis, & Rosenberg, P.A.
1000 NW 57th Court, Suite 600
Miami, FL 33126
RE: The Tariff Classification of MagNA Pure Compact Nucleic Acid Isolation Kit I from Germany
Dear Ms. Stern:
In your letter dated August 19, 2014, you requested a tariff classification ruling on behalf of your client, Roche Diagnostics Operations. The information was submitted to the CBP laboratory for analysis. We apologize for the delay.
You state that the subject merchandise, MagNA Pure Compact Nucleic Acid Isolation Kit I, is comprised of reagents for the isolation of genomic DNA from mammalian whole blood or cultured cells, total nucleic acid isolation from mammalian serum or plasma, or isolation of bacterial DNA from mammalian samples (urine, cerebrospinal fluid, sputum, etc.) using the MagNA Pure Compact Instrument. MagNA Pure Compact Nucleic Acid Kit I, contains 32 sealed multi-well cartridges containing each of the following reagents:
Proteinase K reagent
Lysis Buffer (contains guanidine thiocynate)
Magnetic Glass Particles (MGPs)
Wash Buffer I (contains guanidine hydrochloride)
Wash Buffer II
Wash Buffer III
Elution Buffer
Additionally, you state that the nucleic acid isolation procedure is based on the proven MagNA Pure Magnetic Glass Particle Technology. The principle steps of a MagNA Pure Compact nucleic acid isolation:
1. The samples are lysed by incubation with Proteinase K and a special lysis buffer containing a chaotropic1 salt.
2. MGPs are added and nucleic acids are immobilized on the MGPs’ surfaces.
3. Unbound substances (e.g., proteins, cell debris, PCR2 inhibitors etc.) are removed by several washing steps.
4. Purified nucleic acids are eluted from the MGPs.
Further, you state that your product should be classified in subheading 3822.00.5090, 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; certified reference materials: Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002 or 3006: Other.
We disagree. The Magna Pure Compact Nucleic Acid Isolation kit is used to extract DNA from mammalian or bacterial cells and does not undergo an observable or measureable change. Therefore, the Magna Pure Compact Nucleic Acid Isolation kit is precluded from heading 3822 and will be classified elsewhere.
The applicable classification for MagNA Pure Compact Nucleic Acid Kit I will be in subheading 3824.90.9200, HTSUS, which provides for Chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Other: Other: Other: Other. The rate of duty will be 5 percent ad valorem.
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 http://www.usitc.gov/tata/hts/.
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 Patrick Day at [email protected].
Sincerely,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division