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

N243753 July 31, 2013 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 July 2, 2013, requesting a ruling on the country of origin marking requirements for the QuickVue® Dipstick Strep A Test packaged in Mexico from various materials exported from the United States. You submitted a sample containing 10 tests for our 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 containing heat-inactivated Group A Streptococcus with 0.02% sodium azide, a negative control containing heat-inactivated Group C Streptococcus with 0.02% sodium azide 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 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 manufactured in Mexico. In a follow-up response to our inquiry regarding the plastic tubes (item # 1079200), you stated that you purchase them in the U.S. and then export the plastic tubes to your plant in Mexico for packaging. The remaining items of the kit, including the materials for packaging the tests are from the United States and you stated that everything inside the kit is exported to Mexico from the United 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 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 181). 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