THE COUNTRY OF ORIGIN MARKING OF IMPORTED IN VITRO DIAGNOSTIC IMMUNOFLUORESCENCE KIT; ARTICLE 509

N245309 September 10, 2013 MAR-2 OT:RR:NC:2:238 CATEGORY: MARKING Mr. Michael Nordstrom Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071 RE: THE COUNTRY OF ORIGIN MARKING OF IMPORTED IN VITRO DIAGNOSTIC IMMUNOFLUORESCENCE KIT; ARTICLE 509 Dear Mr. Nordstrom: This is in response to your letter dated August 7, 2013, requesting a ruling on the country of origin marking requirements for the Sofia™ Strep A FIA kit packaged in Mexico. A sample was submitted and will be returned to you. Sofia™ Strep A FIA is an immunofluorescence kit that is indicated for the detection of Group A Streptococcal antigens from throat swabs. It is intended as an aid in the diagnosis of Group A Streptococcal infection. The Sofia™ Strep A FIA test employs immunofluorescence technology that is used with the Sofia analyzer only. Each kit consists of the following: (25) individually packaged test cassettes containing polyclonal rabbit anti-Group A Streptococcus antibodies, (25) reagent extraction tubes, (25) reagent solution bottles containing sodium nitrate and acetic acid, (25) reagent tube dropper tips (25) sterile rayon throat swabs, (1) positive control swab coated with heat-inactivated non-infectious Group A Streptococcus, (1) negative control swab coated with heat-inactivated, non-infectious Group C Streptococcus, (1) package insert, (1) Quick Reference Instructions, (1) QC Card, (1) Translations on CD-ROM and (1) small roll of printer paper. This 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. In your letter, you indicated that all of the components that make up the Sofia™ Strep A FIA kit are manufactured in the United States except for the reagent tube dropper tips (item # 0281201), which are from Mexico, the throat swabs (item #1130500) and the small roll of printer paper (item # 1200800), which are from Italy. 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 packaging operation only. In Mexico, all of the components that make up the Sofia™ Strep A FIA 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 Immunofluorescence 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, Myles B. Harmon Acting Director National Commodity Specialist Division