NY 877026
August 19, 1992
CLA-2-38:S:N:N1-F:238 877026
CATEGORY: Classification
TARIFF NO.: 3822.00.1090
Mr. Paul Blackinton
North American Biologicals, Inc.
16500 N.W. 15th Avenue
Miami, FL 33169
RE: The tariff classification of Visuwell Reagin, an enzyme-
linked immunosorbent assay (ELISA), in kit form, from Canada.
Dear Mr. Blackinton:
In your letter dated June 30, 1992, resubmitted on July 31,
1992, you requested a tariff classification ruling.
Visuwell Reagin is a nontreponemal enzyme-linked
immunosorbent assay (ELISA), in kit form, for the detection of
reagin antibodies as a screening test to detect pathogenic
treponemal infection in syphilis serology. The kit contains the
following components: 1) microwells coated with reagin antigen,
2) positive (reactive human serum) and negative (non-reactive
human serum) controls to ensure proper assay performance, 3)
conjugate "(C)" reagent (urease-conjugated rabbit polyclonal
antibody against human IgG), 4) conjugate diluent "(D)" reagent,
5) urease substrate "(S)" reagent, 6) sodium chloride powder (for
preparation of wash solution), 7) uncoated microwells for
substrate validation, and, 8) a microwell holder.
The literature supplied by you states that the test is
performed with unheated serum or citrated plasma specimens in
microwells coated with cardiolipin, lecithin, and cholesterol.
The cardiolipin antigen will bind with any reagin antibodies that
are present in serum or plasma specimens from syphilitic
patients. The patient's specimen is added directly to the
sensitized microwell and incubated at room temperature. Any
reagin antibodies present in the specimen will bind to the coated
microwell and, after the carrying out of several addtional steps
in the procedure, can be detected visually or by means of an
ELISA reader equipped with a specific type of filter.
The applicable subheading for this product will be
3822.00.1090, Harmonized Tariff Schedule of the United States
(HTS), which provides for composite diagnostic or laboratory
reagents, other than those of heading 3002 or 3006: containing
antigens or antisera: other. The rate of duty will be free.
This merchandise may be subject to the regulations of the
Food and Drug Administration. You may contact them at 5600
Fishers Lane, Rockville, MD 20857, telephone number (202) 443-
3380.
This ruling is being issued under the provisions of Section
177 of the Customs Regulations (19 C.F.R. 177).
A copy of this ruling letter should be attached to the entry
documents filed at the time this merchandise is imported. If the
documents have been filed without a copy, this ruling should be
brought to the attention of the Customs officer handling the
transaction.
Sincerely,
Jean F. Maguire
Area Director
New York Seaport