
{"id":13210,"date":"2026-05-19T07:04:19","date_gmt":"2026-05-19T07:04:19","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/ivd-urununde-intended-purpose-degisikligi-siniflandirmayi-etkiler-mi\/"},"modified":"2026-05-19T07:04:19","modified_gmt":"2026-05-19T07:04:19","slug":"ivd-urununde-intended-purpose-degisikligi-siniflandirmayi-etkiler-mi","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/ivd-urununde-intended-purpose-degisikligi-siniflandirmayi-etkiler-mi\/","title":{"rendered":"IVD \u00fcr\u00fcn\u00fcnde intended purpose de\u011fi\u015fikli\u011fi s\u0131n\u0131fland\u0131rmay\u0131 etkiler mi?"},"content":{"rendered":"<p>IVDR a\u00e7\u0131s\u0131ndan temel de\u011ferlendirme, \u00fcr\u00fcn\u00fcn IVD ama\u00e7lanan kullan\u0131m\u0131, test sonucunun klinik karar \u00fczerindeki etkisi ve s\u0131n\u0131fland\u0131rma kural\u0131d\u0131r. Ama\u00e7lanan kullan\u0131m de\u011fi\u015fikli\u011fi IVDR s\u0131n\u0131f\u0131n\u0131, performans kan\u0131t\u0131n\u0131 ve uygunluk de\u011ferlendirme yolunu de\u011fi\u015ftirebilir. \u00dcretici, performans de\u011ferlendirme dosyas\u0131nda bilimsel ge\u00e7erlilik, analitik performans ve klinik performans kan\u0131tlar\u0131n\u0131 birlikte sunmal\u0131d\u0131r. Kit, yaz\u0131l\u0131m veya numune alma bile\u015feni gibi kombinasyonlarda etiket iddialar\u0131 ile ger\u00e7ek kullan\u0131m senaryosu \u00f6zellikle uyumlu olmal\u0131d\u0131r.<\/p>","protected":false},"excerpt":{"rendered":"<p>IVDR a\u00e7\u0131s\u0131ndan temel de\u011ferlendirme, \u00fcr\u00fcn\u00fcn IVD ama\u00e7lanan kullan\u0131m\u0131, test sonucunun klinik karar \u00fczerindeki etkisi ve s\u0131n\u0131fland\u0131rma kural\u0131d\u0131r. Ama\u00e7lanan kullan\u0131m de\u011fi\u015fikli\u011fi [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"kkqa_category":[448],"kkqa_letter":[467],"class_list":["post-13210","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-ivdr","kkqa_letter-c"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13210","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=13210"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13210\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13210"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13210"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13210"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}