MAR-2 OT:RR:NC:N2:238
Mr. Michael Nordstrom
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee, CA 92071
RE: COUNTRY OF ORIGIN MARKING OF IMPORTED IN VITRO DIAGNOSTIC IMMUNOASSAY KIT; ARTICLE 509
Dear Mr. Nordstrom:
This is in response to your letter dated May 8, 2012, requesting a ruling on the country of origin marking requirements for QuickVue® + Infectious Mononucleosis Test, packaged in Mexico from various materials exported from the United States. A sample was submitted with your letter for review.
QuickVue® + Infectious Mononucleosis Test, is a rapid, color ImmunoChromatographic Assay (CICA) kit for the detection of Infectious Mononucleosis IgM heterophile antibodies in serum, plasma or whole blood. This test is intended to aid in the diagnosis of Infectious Mononucleosis. It consists of the following: 20 individually wrapped plastic reaction units containing anti-human IgM and immobilized extracted bovine erythrocyte antigens, 5mL developer containing detergent, 1 mL mono negative control containing normal human serum diluted in saline solution, 1mL mono positive control containing IgM heterophile antibody positive human plasma diluted in saline solution, 20 plastic pipettes, 20 capillary tubes and instructional leaflets. The kit is put up ready for retail sale inside a printed box with the outer surface of the box labeled with the name of the manufacturer, Quidel Corporation of San Diego, CA. According to the product literature submitted to this office, the Infectious Mononucleosis Test is intended for use by health care professionals only.
In your letter, you indicated that all of the components that make up the QuickVue® + Infectious Mononucleosis Test are manufactured in the United States except for the pipettes (item # 0323101) which are from Mexico and the 3x 5 plastic reclose bag (item # 0823200) which is from Thailand. You also indicate that all of the materials for packaging the tests are from the United States. In Mexico, all of the components that make up the QuickVue® + Infectious Mononucleosis Test Kit will be placed into the printed box, labeled with a lot number, expiration date, sealed and packaged. Afterwards, Scantibodies Laboratory, Inc. will import the kit into the United States directly from Mexico for distribution.
The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304.
The country of origin marking requirements for a “good of a NAFTA country” are also determined in accordance with Annex 311 of the North American Free Trade Agreement (“NAFTA”), as implemented by section 207 of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat 2057) (December 8, 1993) and the appropriate Customs Regulations. The Marking Rules used for determining whether a good is a good of a NAFTA country are contained in Part 102, Customs Regulations (19 CFR Part 102). Section 102.11 of the regulations, sets forth the required hierarchy for determining country of origin for marking purposes.
Applying the NAFTA Marking Rules set forth in Part 102 of the regulations to the facts of this case, we find the imported In Vitro Diagnostic Immunoassay Kit is a good of the United States for marking purposes.
If a good is determined to be an article of U.S. origin, it is not subject to the country of origin marking requirements of 19 U.S.C. §1304. Whether an article may be marked with the phrase "Made in the USA" or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC). We suggest that you contact the FTC Division of Enforcement, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580 on the propriety of proposed markings indicating that an article is made in the U.S.
This ruling is being issued under the provisions of Part 181 of the Customs Regulations (19 CFR Part 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 Judy Lee at (646) 733-3033.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division