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
The ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2 From Therapeutic Goods Administration (TGA) 🇦🇺 Information on the TGA post-market review of all point-of-care and laboratory tests included in the ARTG that are intended to identify patients with COVID-19 to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate. 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 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices From European Commission 🇪🇺 Notice to manufacturers and authorised representatives on the impact of genetic variants on COVID-19 diagnostic devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on pharmacogenetic tests and genetic tests for heritable markers. 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 February 28, 2020 Other (Public Domain) 0 reuses 0 favorites
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on using public genetic variant databases to support clinical validity for in vitro diagnostics. 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 9, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-24159. The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language… 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 7, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-25049. The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory… 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 October 22, 2014 Other (Public Domain) 0 reuses 0 favorites
Circular of the General Office of the Food and Drug Administration on the Classification Definition of Genetic Analyzers and Three Other Products From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2014-10027 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 14, 2014 Other (Public Domain) 0 reuses 0 favorites