This is the application form for the dossier containing the necessary information about a diagnostic kit to be submitted to the OIE for certification of "fitness for purpose".
Before filling in the form and submitting an application, applicants should read “Standard Operating Procedure (SOP) for OIE Registration of Diagnostic Kits: Guide and Administrative Forms”.
The chapter 1.1.5., “Principles and methods of validation of diagnostic assays for infectious diseases” of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals should be also read (available on the OIE website at : http://www.oie.int/en/international-standard-setting/terrestrial-manual/access-online/). It deals with principles of validation and therefore could be helpful when filling in this dossier.
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OIE procedure for validation and certification of the diagnostic assays
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