{"id":4370,"date":"2022-10-20T15:58:40","date_gmt":"2022-10-20T13:58:40","guid":{"rendered":"https:\/\/idldiagnostics.com\/?page_id=4370"},"modified":"2025-05-27T11:32:56","modified_gmt":"2025-05-27T09:32:56","slug":"quality-assurance","status":"publish","type":"page","link":"https:\/\/idldiagnostics.com\/se\/products\/quality-assurance\/","title":{"rendered":"Kvalitetss\u00e4kring"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;88f366a5-bf49-48d9-a338-ab22706b73e7&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;2_3,1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||||false|false&#8221; custom_padding_tablet=&#8221;10px||||false|false&#8221; custom_padding_phone=&#8221;0px||||false|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][dipi_breadcrumbs _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;800px&#8221; global_module=&#8221;5132&#8243; global_colors_info=&#8221;{}&#8221;][\/dipi_breadcrumbs][et_pb_divider color=&#8221;#EEEEEE&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; min_height=&#8221;1px&#8221; height=&#8221;20px&#8221; custom_margin=&#8221;||3px|||&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][et_pb_text _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;8738c908-7375-4c6c-99a7-9f91f8a3c099&#8243; header_font_size=&#8221;56px&#8221; custom_margin=&#8221;||17px|||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h6>Products<\/h6>\n<h1>Quality Assurance<\/h1>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;50px||||false|false&#8221; custom_padding_tablet=&#8221;10px||||false|false&#8221; custom_padding_phone=&#8221;0px||||false|false&#8221; custom_padding_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.17.3&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px|||||&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.17.3&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text module_id=&#8221;Regulatory&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; min_height=&#8221;260.7px&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h3>Regulatory information<\/h3>\n<p>IDL Diagnostics is developing, manufacturing, and distributing in vitro diagnostic products regulated under the IVD directive of the European Union. IDL Diagnostics products TK 210 ELISA are CE-marked and registered as in vitro diagnostic medical devices at the Swedish Medical Products Agency (MPA), the Swedish Competent Authority responsible for market surveillance related to the law on medical devices.<\/p>\n<p>IDL Diagnostics subsidiary, IDL Biotech, is manufacturing and distributing UBC\u00ae Rapid, TUBEX\u00ae TF, and TUBEX\u00ae TF Wash. <span><span lang=\"EN-US\">In addition, <\/span><\/span><span>TPS\u00ae<\/span><span lang=\"EN-US\"> ELISA is also manufactured but only for distribution in China.<\/span> IDL Biotech\u2019s other ELISA\/IRMA products, MonoTotal\u00ae, TPS\u00ae, TPAcyk\u2122, and UBC are out-licensed and are manufactured and distributed by Beckman Coulter.<\/p>\n<p>TUBEX\u00ae, TPS\u00ae , UBC\u00ae , MonoTotal\u00ae and TPAcyk\u2122 are trademarks of IDL Biotech.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/idldiagnostics.com\/wp-content\/uploads\/2022\/10\/IDL_2593web.jpg&#8221; title_text=&#8221;IDL_2593web&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px|||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>IDL Biotech meets high quality standards, and all of the products are developed, manufactured, and supplied to the market according to EN ISO 13485:2016 standardized procedures, and CE marked in accordance with the European IVD directive.\u00a0<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;https:\/\/idldiagnostics.com\/wp-content\/uploads\/2025\/01\/2087843-EN-ISO-13485-2016.pdf&#8221; url_new_window=&#8221;on&#8221; button_text=&#8221;EN ISO 13485:2016&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.17.4&#8243; _module_preset=&#8221;default&#8221; global_module=&#8221;3323&#8243; saved_tabs=&#8221;all&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_menu menu_id=&#8221;51&#8243; disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_menu][et_pb_sidebar area=&#8221;et_pb_widget_area_10&#8243; disabled_on=&#8221;off|off|on&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;2efbbc8f-7ecb-4fe3-9956-d83a8a0e7a74&#8243; background_color=&#8221;#F8F8F8&#8243; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_sidebar][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|tablet&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding_tablet=&#8221;||0px||false|false&#8221; custom_padding_phone=&#8221;&#8221; global_module=&#8221;2175&#8243; saved_tabs=&#8221;all&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#21242A&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h6>Investors<\/h6>\n<h3>We are listed on NASDAQ First North Growth Market.<\/h3>\n<p>We want to be the obvious choice within our segment in the markets where we are established. The market for our products is large and we are a smaller player with significant growth potential so far. IDL Diagnostics is unique for a company of this size.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;https:\/\/idldiagnostics.com\/investors\/&#8221; button_text=&#8221;Read more about investing&#8221; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;5e8c1032-9074-49bb-92a6-99c20ecc3d02&#8243; global_colors_info=&#8221;{}&#8221;][\/et_pb_button][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/idldiagnostics.com\/wp-content\/uploads\/2022\/10\/MG_3045.jpg&#8221; title_text=&#8221;_MG_3045&#8243; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p><div class=\"et_pb_module dipi_breadcrumbs dipi_breadcrumbs_0\">\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<div class=\"et_pb_module_inner\">\n\t\t\t\t\t<div class=\"dipi-breadcrumbs dipi-bc-left\">\n                <ul >\n                    \n                                                        <li  class=\"dipi-breadcrumb-item dipi-breadcrumb-home\">\n\n                                                    <a  href=\"https:\/\/idldiagnostics.com\/se\">\n                                <span  content=\"Home\">\n                                                                        IDL Diagnostics                                <\/span>\n                            <\/a>\n\n                                                <meta itemprop=\"position\" content=\"1\"\/>                    <\/li>\n\n                    <li class=\"dipi-breadcrumb-separator\">\n                    <span class=\"et-pb-icon dipi-separator-icon\">&#x35;<\/span>\n                <\/li>                            \n                <\/ul>\n            <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>Products Quality AssuranceRegulatory information IDL Diagnostics is developing, manufacturing, and distributing in vitro diagnostic products regulated under the IVD directive of the European Union. IDL Diagnostics products TK 210 ELISA are CE-marked and registered as in vitro diagnostic medical devices at the Swedish Medical Products Agency (MPA), the Swedish Competent [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":4377,"parent":54,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"dipi_cpt_category":[],"class_list":["post-4370","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quality Assurance | Regulatory information - IDL Diagnostics<\/title>\n<meta name=\"description\" content=\"Quality Assurance - We meet high quality standards, and all of the products are developed and manufactured, according to EN ISO 13485:2016\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/idldiagnostics.com\/se\/products\/quality-assurance\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality Assurance | Regulatory information - 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