COUNTRY OF ORIGIN MARKING OF IMPORTED IN VITRO DIAGNOSTIC IMMUNOASSAY KITS; ARTICLE 509

N217606 June 14, 2012 MAR-2 OT:RR:NC:N2:238 CATEGORY: MARKING Mr. Michael Nordstrom Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071 RE: COUNTRY OF ORIGIN MARKING OF IMPORTED IN VITRO DIAGNOSTIC IMMUNOASSAY KITS; 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® Dipstick Strep ATest packaged in Mexico from various materials exported from the United States. Three samples were submitted with your letter for review. QuickVue® Dipstick Strep A Test is a rapid, lateral-flow immunoassay kit for the detection of Group A Streptococcal antigen from throat swabs. The test is intended to aid in the diagnosis of Group A Streptococcus infection. Each kit consists of individually wrapped dipsticks coated with rabbit polyclonal anti-Group A Streptococcus, 1 Reagent A containing 4 M sodium nitrite, 1 Reagent B containing 0.2 M acetic acid, sterile throat swabs, plastic tubes, a positive control with heat-inactivated Group A Streptococcus and 0.02% sodium azide, a negative control with heat-inactivated Group C Streptococcus with 0.02% sodium azide and instructional leaflets. The QuickVue® Dipstick Strep A Test is available in quantities of 4 tests, 25 tests and 50 tests. Each 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 QuickVue® Dipstick Strep A Test is intended for use by health care professionals only. In your letter, you indicated that all of the components that make up QuickVue® Dipstick Strep A Test are manufactured in the United States except for the plastic tubes which are from Mexico and the sterile throat swabs which are from Italy. You also indicate that all of the materials for packaging the tests are from the United States and everything inside the kit is exported to Mexico from the Unites States for simple packing. In Mexico, all of the components that make up the QuickVue® Dipstick Strep A Test 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 Kits are goods 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. Your inquiry also does not provide enough information for us to give a country of origin marking determination on Strep A dpskt 50T - Medinor and Strep A dpskt 25T –Japan Influenza. We need additional information in order to issue a ruling on these products. The samples you submitted did not match up with the literature. Please submit technical literature for each item, including the manufacturing process of the kit along with a list of the contents and indicate in which country each component is manufactured. If you decide to resubmit your request, please mail your request to U.S. Customs and Border Protection, Customs Information Exchange, 10th Floor, One Penn Plaza, New York, NY 10119, attn: Binding Rulings Section. 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