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 or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-20896. The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect or measure nucleic acid from viruses associated with head and neck cancers into class II (special controls). The special controls that apply to the device type are identified in… 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 3 days ago Other (Public Domain) 0 reuses 0 favorites
Post-market review of HIV nucleic acid tests From Therapeutic Goods Administration (TGA) 🇦🇺 Find out more about the post-market review the TGA is undertaking on human immunodeficiency virus (HIV) nucleic acid tests (NATs). 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on evaluating performance characteristics of in vitro diagnostic devices for detecting and differentiating influenza viruses. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Hepatitis B and C viruses IVD self-tests From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance on the TGA's expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for hepatitis B virus (HBV) and hepatitis C virus (HCV). 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 November 29, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Information for patients: A guide to antigen self-testing for COVID-19 From Health Canada 🇨🇦 Self-testing allows people to test themselves or their dependants for SARS-CoV-2, the virus that causes COVID-19. These tests provide a snapshot of your current infection status. This guide should be read in addition to the instructions for use that are provided with the test. 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 February 16, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-23868. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to… 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 November 4, 2022 Other (Public Domain) 0 reuses 0 favorites
Surrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19 From Therapeutic Goods Administration (TGA) 🇦🇺 Frequently asked questions added 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 7, 2022 Other (Non-Commercial) 0 reuses 0 favorites
ACMD advice on Hepatitis C and Human Immunodeficiency Virus point of care tests From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA asked the ACMD to consider acceptable levels of sensitivity and specificity for Hepatitis C (HCV) and Human Immunodeficiency Virus (HIV) PoCTs 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 June 21, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-10461. The Food and Drug Administration (FDA, we, or the Agency) is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class… 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, 2022 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25372. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, a postamendments class III device with the product code MZF, into class II (special controls), subject to premarket… 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 November 24, 2021 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25379. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class… 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 November 22, 2021 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25374. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general… 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 November 22, 2021 Other (Public Domain) 0 reuses 0 favorites
Notice concerning Medical Devices under Directive 93/42/EEC which contain live micro-organisms, bacteria, fungi or viruses. From National Organization for Medicines (EOF) 🇬🇷 The E.O.F. informs manufacturers, authorised dealers and distributors of products incorporating or incorporating ... 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 9, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory From Health Canada 🇨🇦 2011 Health Canada guidance document 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 March 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-06820. The Food and Drug Administration (FDA or Agency) is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices… 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 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-06821. The Food and Drug Administration (FDA or Agency) is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and… 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 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Notice of the Comprehensive Department of the State Drug Administration on Cracking Down on the Illegal Manufacture and Sale of New Crown Pneumonia Virus Test Reagents From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-10001 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-03515. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices with… 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 February 21, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-01725. The Food and Drug Administration (FDA, the Agency, or we) is classifying the human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology into class II (special controls). The special controls that apply to the… 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 February 7, 2020 Other (Public Domain) 0 reuses 0 favorites