
{"id":13203,"date":"2026-05-19T07:04:19","date_gmt":"2026-05-19T07:04:19","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/ivd-kit-nedir-ve-ivdr-kapsaminda-nasil-degerlendirilir\/"},"modified":"2026-05-19T07:04:19","modified_gmt":"2026-05-19T07:04:19","slug":"ivd-kit-nedir-ve-ivdr-kapsaminda-nasil-degerlendirilir","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/ivd-kit-nedir-ve-ivdr-kapsaminda-nasil-degerlendirilir\/","title":{"rendered":"IVD kit nedir ve IVDR kapsam\u0131nda nas\u0131l de\u011ferlendirilir?"},"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. IVD kit; birlikte kullan\u0131lan bile\u015fenlerin ama\u00e7lanan kullan\u0131m\u0131na g\u00f6re de\u011ferlendirilir ve kit olarak piyasaya arz edilen b\u00fct\u00fcnl\u00fck ayr\u0131 sorumluluk do\u011furabilir. \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. IVD kit; birlikte [&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-13203","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\/13203","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=13203"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13203\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13203"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13203"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13203"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}