CLA-2-38:RR:NC:2:238 D84807
Mr. Arnaud Schmutz
Project Manager
Biosepra Inc.
111 Locke Drive
Marlborough, MA 01752
RE: The tariff classification of Heparin HyperD 20 m, Heparin
HyperD M, Blue Ceramic HyperD , Lysine Ceramic HyperD , and
Methyl Ceramic HyperD chromatographic media, in bulk form,
from France
Dear Mr. Schmutz:
In your letter dated August 19, 1998, you requested a tariff
classification ruling. Technical information was submitted. We
apologize for the delay in our response.
Heparin HyperD 20 m (Part #200750), Heparin HyperD M (Part
#200290), Blue Ceramic HyperD (Part #200310), and Lysine Ceramic
HyperD (Part #200590) are characterized as affinity
chromatographic media, while Methyl Ceramic HyperD (Part
#200510) is a hydrophobic interaction chromatographic (HIC)
medium. All are in bulk form.
According to the technical information you submitted,
Ceramic HyperD media are a range of chromatographic sorbents
used for the purification and preparation of protein substances
in the laboratory or in industry, the final destination being
related to the particle size and particle size distribution
(small particles are used at laboratory scale, large particles
for high productivity at industrial scale). They are designed for
separation in aqueous solutions.
In general, Ceramic HyperD media are composite materials in
bead form consisting of a co-polymeric crosslinked network
(hydrogel) distributed inside the pores of a rigid, mineral
(mixture of sintered zirconium and calcium silicates) "ceramic"
support (substrate). The substrate acts as a solid skeleton,
while the hydrogel polymer governs the exchange mechanism for
macromolecule or particle adsorption. The polymer provides a
tridimensional network for the capture of separated molecules. It
is insoluble in any solvent, thus preventing the loss of any
captured molecules. Affinity ligands are chemically attached to
the hydrogel polymers at one end, leaving the other end free to
react with the targeted substance to form a complex or
coordination compound with that substance. The presence of
specific ligands induces, at given pH and ionic strength
conditions, a selective adsorption, through the bead-hydrogel
structure carrying the ligand, of molecules such as proteins. The
adsorbed proteins can then be selectively eluted at precise
conditions designed for affinity separation.
Heparin HyperD 20 m and Heparin HyperD M utilize a heparin
ligand which specifically interacts with biological products that
bind to heparin, such as coagulating factors, growth factors,
lipoproteins, etc. These products appear to be particularly
efficacious in the purification and production of Antithrombin
III. Blue Ceramic HyperD utilizes a Basilen Blue dye as the
ligand. This dye bears a specific site that mimics bilirubin and,
therefore, binds to albumin. Lysine Ceramic HyperD has an amino
acid ligand (lysine). Generally, amino acid chemistry media are
utilized in production of serum proteins, peptides, enzymes, etc.
The Methyl Ceramic HyperD is a medium filled with hydrophobic (-CH3) functionalized hydrogel. This product has broad application
in the purification of proteins.
The applicable subheading for the Heparin HyperD 20 m,
Heparin HyperD M, Blue Ceramic HyperD , Lysine Ceramic HyperD ,
and Methyl Ceramic HyperD will be 3822.00.5090, Harmonized
Tariff Schedule of the United States (HTS), which provides for
"[d]iagnostic 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: [o]ther: [o]ther." The
rate of duty will be 1 percent ad valorem.
This merchandise may be subject to the requirements of the
Federal Food, Drug, and Cosmetic Act, which is administered by
the U.S. Food and Drug Administration. You may contact them at
5600 Fishers Lane, Rockville, Maryland 20857, telephone number
(301)443-6553.
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 Harvey
Kuperstein at 212-466-5770.
Sincerely,
Robert B. Swierupski
Director,
National Commodity
Specialist Division