21 CFR Chapter I Subchapter H – Medical Devices – Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) 🇺🇸 Regulation on Immunology and Microbiology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 866. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 88.88888888888889/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-18266. The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 16, 2024 Other (Public Domain) 0 reuses 0 favorites
COVID-19 rapid antigen self-tests that are approved in Australia From Therapeutic Goods Administration (TGA) 🇦🇺 A list of approved COVID-19 tests included in the ARTG for supply in Australia. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Legal supply of COVID-19 test kits From Therapeutic Goods Administration (TGA) 🇦🇺 Updated information about the legal supply of COVID-19 test kits Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 serology point-of-care tests From Therapeutic Goods Administration (TGA) 🇦🇺 Information about COVID-19 serology point-of-care tests. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 Personal Protective Equipment (PPE) From Therapeutic Goods Administration (TGA) 🇦🇺 Information on PPE and hand sanitisers for use against COVID-19. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 test approval: how to apply From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How test manufacturers or distributors can apply for approval of their tests to sell on the UK market. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 24, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Instructions for sponsors who have interest in supplying a COVID-19 self-test From Therapeutic Goods Administration (TGA) 🇦🇺 New information about importing self-tests. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 testing in Australia: information for health professionals From Therapeutic Goods Administration (TGA) 🇦🇺 Find information on the different types of COVID-19 tests and how we assess them and monitor their performance. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 test kits included in the ARTG for legal supply in Australia From Therapeutic Goods Administration (TGA) 🇦🇺 View COVID-19 tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG). Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 home use tests From Therapeutic Goods Administration (TGA) 🇦🇺 Use and interpret the results from COVID-19 home use tests Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG From Therapeutic Goods Administration (TGA) 🇦🇺 Update to information about applying for assessment of a COVID-19 test for inclusion in the ARTG. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Q&As on conditions of supply for rapid antigen point of care COVID-19 tests From Therapeutic Goods Administration (TGA) 🇦🇺 Answers to frequently asked questions in relation to rapid antigen point-of-care tests. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 rapid antigen self-tests (for home use) From Therapeutic Goods Administration (TGA) 🇦🇺 Information for sponsors, manufacturers and consumers on COVID-19 rapid antigen tests for self-testing Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 point-of-care tests From Therapeutic Goods Administration (TGA) 🇦🇺 Information about COVID-19 point-of-care tests. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 in vitro diagnostics - Guidance on ongoing requirements for sponsors and manufacturers From Therapeutic Goods Administration (TGA) 🇦🇺 A guide for sponsors of COVID-19 IVDs about their ongoing obligations Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Special topic pages From Therapeutic Goods Administration (TGA) 🇦🇺 Special topic pages for advertising, including COVID-19, medicinal cannabis, nicotine vaping products and disease education. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 test validation approved products From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Find out which COVID-19 test products have been approved. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 25, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
COVID-19 health product industry From Health Canada 🇨🇦 Links to COVID-19-related information for health product manufacturers and distributors of diagnostic tests, ventilators, hand sanitizers and disinfectants. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 15, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
European medical device regulations From Ministry of Health (Italy) (MDS) 🇮🇹 Medical device sector is of great importance in healthcare in Europe, contributing to the improvement of the level of health protection through the development of innovative solutions for diagnosis, prevention, treatment and rehabilitation. Since the early 2020s, due to the SARS-CoV-2 pandemic,… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites