{"id":18713,"date":"2022-04-07T13:28:19","date_gmt":"2022-04-07T11:28:19","guid":{"rendered":"https:\/\/www.cofgipuzkoa.eus\/informacion-sobre-el-test-de-diagnostico-in-vitro-sars-cov-2-antigen-rapid-test-kit\/"},"modified":"2022-04-07T13:28:19","modified_gmt":"2022-04-07T11:28:19","slug":"informacion-sobre-el-test-de-diagnostico-in-vitro-sars-cov-2-antigen-rapid-test-kit","status":"publish","type":"post","link":"https:\/\/www.cofgipuzkoa.eus\/eu\/informacion-sobre-el-test-de-diagnostico-in-vitro-sars-cov-2-antigen-rapid-test-kit\/","title":{"rendered":"INFORMACI\u00d3N SOBRE EL TEST DE DIAGN\u00d3STICO IN VITRO \u201cSARS-COV-2 ANTIGEN RAPID TEST KIT"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column width=&#8221;1\/1&#8243;][vc_column_text]La Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento de la presencia en el mercado espa\u00f1ol de unidades del test \u201cSARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)\u201d, fabricado por la empresa china Beijing Lepu Medical Techonology Co., Ltd., con las siguientes no conformidades:<\/p>\n<p>La caja exterior del kit contiene una pegatina con la indicaci\u00f3n \u201cfor self-testing\u201d (para autodiagn\u00f3stico) y el marcado CE seguido del n\u00famero 0197. La pegatina est\u00e1 colocada sobre el marcado CE original del kit sin n\u00famero, lo que indica que no ha intervenido el organismo notificado (ON) 0197 en la evaluaci\u00f3n de la conformidad. Por todo lo anterior, se tratar\u00eda de un test de uso profesional que est\u00e1n comercializando como de autodiagn\u00f3stico.<\/p>\n<p><a href=\"https:\/\/www.aemps.gob.es\/informa\/notasinformativas\/productossanitarios\/2022-ps\/informacion-sobre-el-test-de-diagnostico-in-vitro-sars-cov-2-antigen-rapid-test-kit-colloidal-gold-immunochromatography-fabricado-por-beijing-lepu-medical-technology-co-ltd\/\" target=\"_blank\" rel=\"noopener noreferrer\">Ver Comunicado AEMPS<\/a>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column width=&#8221;1\/1&#8243;][vc_column_text]La Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento de la presencia en el mercado espa\u00f1ol de unidades del test \u201cSARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)\u201d, fabricado por la empresa china Beijing Lepu Medical Techonology Co., Ltd., con las siguientes no conformidades: La caja exterior del kit contiene una pegatina con la indicaci\u00f3n \u201cfor self-testing\u201d (para autodiagn\u00f3stico) y el marcado CE seguido del n\u00famero 0197. La pegatina est\u00e1 colocada sobre el marcado CE original del kit sin n\u00famero, lo que indica que no ha intervenido el organismo notificado (ON) 0197 en la evaluaci\u00f3n de la conformidad. Por todo lo anterior, se tratar\u00eda de un test de uso profesional que est\u00e1n comercializando como de autodiagn\u00f3stico. Ver Comunicado AEMPS[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"author":1105,"featured_media":18712,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"footnotes":""},"categories":[164],"tags":[],"class_list":["post-18713","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-alertak"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>INFORMACI\u00d3N SOBRE EL TEST DE DIAGN\u00d3STICO IN VITRO \u201cSARS-COV-2 ANTIGEN RAPID TEST KIT - Colegio Oficial de Farmac\u00e9uticos de Gipuzkoa - Gipuzkoako Farmazilarien Elkargo Ofiziala<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cofgipuzkoa.eus\/?p=18710\" \/>\n<meta property=\"og:locale\" content=\"eu_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"INFORMACI\u00d3N SOBRE EL TEST DE DIAGN\u00d3STICO IN VITRO \u201cSARS-COV-2 ANTIGEN RAPID TEST KIT - Colegio Oficial de Farmac\u00e9uticos de Gipuzkoa - Gipuzkoako Farmazilarien Elkargo Ofiziala\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column width=&#8221;1\/1&#8243;][vc_column_text]La Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento de la presencia en el mercado espa\u00f1ol de unidades del test \u201cSARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)\u201d, fabricado por la empresa china Beijing Lepu Medical Techonology Co., Ltd., con las siguientes no conformidades: La caja exterior del kit contiene una pegatina con la indicaci\u00f3n \u201cfor self-testing\u201d (para autodiagn\u00f3stico) y el marcado CE seguido del n\u00famero 0197. La pegatina est\u00e1 colocada sobre el marcado CE original del kit sin n\u00famero, lo que indica que no ha intervenido el organismo notificado (ON) 0197 en la evaluaci\u00f3n de la conformidad. Por todo lo anterior, se tratar\u00eda de un test de uso profesional que est\u00e1n comercializando como de autodiagn\u00f3stico. Ver Comunicado AEMPS[\/vc_column_text][\/vc_column][\/vc_row]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.cofgipuzkoa.eus\/?p=18710\" \/>\n<meta property=\"og:site_name\" content=\"Colegio Oficial de Farmac\u00e9uticos de Gipuzkoa - Gipuzkoako Farmazilarien Elkargo Ofiziala\" \/>\n<meta property=\"article:published_time\" content=\"2022-04-07T11:28:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.cofgipuzkoa.eus\/wp-content\/uploads\/2022\/04\/COLLOIDAL-GOLD-ANTIGEN-RAPID-TEST-KIT.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"620\" \/>\n\t<meta property=\"og:image:height\" content=\"350\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"ARITZ RIVERO ASTIZ\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@GipuzkoaCOF\" \/>\n<meta name=\"twitter:site\" content=\"@GipuzkoaCOF\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"ARITZ RIVERO ASTIZ\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.cofgipuzkoa.eus\/?p=18710#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.cofgipuzkoa.eus\/?p=18710\"},\"author\":{\"name\":\"ARITZ RIVERO ASTIZ\",\"@id\":\"https:\/\/www.cofgipuzkoa.eus\/#\/schema\/person\/6a93d28dd316a1a66e66d6a4bc2a6324\"},\"headline\":\"INFORMACI\u00d3N SOBRE EL TEST DE DIAGN\u00d3STICO IN VITRO \u201cSARS-COV-2 ANTIGEN RAPID TEST KIT\",\"datePublished\":\"2022-04-07T11:28:19+00:00\",\"dateModified\":\"2022-04-07T11:28:19+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.cofgipuzkoa.eus\/?p=18710\"},\"wordCount\":160,\"publisher\":{\"@id\":\"https:\/\/www.cofgipuzkoa.eus\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.cofgipuzkoa.eus\/?p=18710#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.cofgipuzkoa.eus\/wp-content\/uploads\/2022\/04\/COLLOIDAL-GOLD-ANTIGEN-RAPID-TEST-KIT.jpg\",\"articleSection\":[\"Alertak\"],\"inLanguage\":\"eu-ES\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.cofgipuzkoa.eus\/?p=18710\",\"url\":\"https:\/\/www.cofgipuzkoa.eus\/?p=18710\",\"name\":\"INFORMACI\u00d3N SOBRE EL TEST DE DIAGN\u00d3STICO IN VITRO \u201cSARS-COV-2 ANTIGEN RAPID TEST KIT - 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