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Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home
… ouncements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home … Español Today, the U.S. Food and … issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that …
Tìm hiểu thuật ngữ quy định về các loại thuốc phòng ngừa và điều trị COVID-19 tiềm năng
… thuat-ngu-quy-dinh-ve-cac-loai-thuoc-phong-ngua-va-dieu-tri-covid-19-tiem-nang … English Các nhà khoa học liên tục nghiên cứu … các loại thuốc tiềm năng trong việc phòng ngừa và điều trị COVID-19. Ngôn ngữ được sử dụng để mô tả các loại thuốc tiềm …
At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results: FDA Safety Communication
… to the need for repeat testing following a negative COVID-19 test result on COVID-19 antigen tests -- revising the emergency use …
Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine - 12/04/2020
… ficials/remarks-dr-hahn-national-academy-medicine-town-hall-covid-19-vaccine-12042020 … Thank you for being here today for this … HHS colleagues would agree, working together tirelessly on COVID-19 has further strengthened our already close working …
Understanding the Regulatory Terminology of Potential Preventative and Therapeutic Drugs for COVID-19
… ry-terminology-potential-preventative-and-therapeutic-drugs-covid-19 … Español 简体中文 한국어 Tagalog Việt Scientists … potential drugs for the prevention and treatment of COVID-19. The language used to describe potential drugs can …
Pag-unawa sa Panregulatoryong Terminolohiya ng mga Gamot na Potensyal na Pang-iwas sa Sakit at Terapeutiko para sa COVID-19
… ng mga potensyal na gamot para sa pag-iwas at paggamot sa COVID-19. Maaaring nakakalito ang wikang ginamit sa paglalarawan sa … para sa mga produkto upang magamot o maiwasan ang COVID-19, inaprubahan at inawtorisahan ng FDA ang ilang gamot …
Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test
… virus-covid-19-update-fda-issues-new-authorization-binaxnow-covid-19-ag-card-home-test … Español Today, the U.S. Food and Drug … a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by …
La FDA emite autorización para el sistema de prueba de anticuerpos recolectados por uno mismo Symbiotica COVID-19
… de anticuerpos recolectados por uno mismo Symbiotica COVID-19, la primera prueba de anticuerpos autorizada para su uso … a causa de una infección reciente o anterior por el COVID-19", dijo Jeff Shuren, M.D., J.D., director del Centro …
Actualización sobre el coronavirus (COVID-19): La FDA alerta a los consumidores sobre los kits de prueba para el COVID-19 fraudulentos no autorizados
… ress-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-alerta-los-consumidores-sobre-los-kits-de-prueba … … el diagnóstico, prevención y tratamiento del coronavirus (COVID-19), como parte de nuestros esfuerzos continuos para proteger …
Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA
… /medical-device-recalls/jiangsu-well-biotech-co-ltd-recalls-covid-19-ag-rapid-test-devices-are-not-authorized-cleared-or … The … serious injuries or death. Recalled Product Product Name: COVID-19 Ag Rapid Test Device Product Codes: See Recall …
Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19
… over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a …
FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses
… izes-first-over-counter-home-test-detect-both-influenza-and-covid-19-viruses … Español Today, the U.S. Food and Drug … known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use …
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only
… e-recalls/celltrion-usa-recalls-certain-point-care-diatrust-covid-19-ag-rapid-test-kits-labeled-research-use … The FDA has … death. Recalled Product Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test (labeled for Research Use Only) …
Actualización sobre el coronavirus (COVID-19): la FDA autoriza la prueba Quidel QuickVue At-Home COVID-19
… ress-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-la-prueba-quidel-quickvue-home-covid-19 … English Hoy, la Administración de Alimentos y …
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users
… e-recalls/celltrion-usa-recalls-certain-point-care-diatrust-covid-19-ag-rapid-test-kits-which-may-have-been … The FDA has … death. Recalled Product Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Codes: 83QKP Lot Numbers: See …
SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
… edical-device-recalls/sd-biosensor-recalls-standard-q-covid-19-ag-home-tests-are-not-authorized-cleared-or-approved-fda … … Recalled Product Product Name: SD Biosensor STANDARD Q COVID-19 Ag Home Test Product Codes and Lot Numbers: See recall …
Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs
… coronavirus-covid-19-update-fda-takes-steps-streamline-path-covid-19-screening-tools-provides … Español Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and …
SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
… e-recalls/sml-distribution-llc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not … The FDA has … communication, Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests . Recalled Product Product Names: Skippack …
Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life
… celltrion-usa-recalls-certain-point-care-celltrion-diatrust-covid-19-ag-rapid-tests-false-positive … The FDA has identified … death. Recalled Product Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See …
Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
… recalls/universal-meditech-inc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not … The FDA has … communication Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests . Recalled Product Product Names: Skippack …
Actualización sobre el COVID-19: La FDA autoriza la primera prueba diagnóstica donde los resultados se pueden leer directamente de la tarjeta de prueba
… uso de un analizador. “Esta nueva prueba de antígeno del COVID-19 es una adición importante a las pruebas ya disponibles … ha sido autorizada para uso en pacientes con sospecha del COVID-19 por su proveedor de atención médica dentro de los …
E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
… (Include the following information) Product Names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade Name: E25Bio SARS-CoV-2 … Initiated by Firm: January 27, 2022 Device Use The E25Bio COVID-19 Direct Antigen Rapid Test is used to detect proteins …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza la primera prueba de diagnóstico de COVID-19 que utiliza muestras de aliento
… ents/press-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-la-primera-prueba-de-diagnostico-de … … siglas en inglés) para la primera prueba de diagnóstico de COVID-19 que detecta compuestos químicos en muestras de …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza una prueba de diagnóstico combinado adicional para el COVID-19 antes de la temporada de gripe
… ents/press-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-una-prueba-de-diagnostico-combinado … … para la próxima temporada de gripe durante la pandemia del COVID-19 mediante la emisión de una Autorización para Uso …
Actualización sobre el coronavirus (COVID-19): La FDA autoriza la primera prueba de COVID-19 para autodiagnosticarse en el hogar
… ents/press-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-la-primera-prueba-de-covid-19-para … English Hoy, la Administración de Alimentos y …