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The applicant shall submit the prototype and the laboratory manual, in English or French, including the completed FDA Form 1789 that describes the proposed Confirmation and Documentation System, as well as the Mark Declaration form included within the prototype packaging. Such submissions shall be made within 30 days of this June 1, 2016 final action on this listing.

Overview of the Proposed Confirmation and Documentation SystemThe proposed SIR (Screening Information Report) is an electronic

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