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
21 CFR Chapter I Subchapter H – Medical Devices – Part 862 Clinical Chemistry and Clinical Toxicology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H - Medical Devices - Part 862 Clinical Chemistry and Clinical Toxicology Devices". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on February 5, 2024 Other (Public Domain) 0 reuses 0 favorites
Off-label advertising and sale of COVID-19 rapid antigen tests under workplace screening initiative: Interim enforcement approach From Health Canada 🇨🇦 Medical Devices Establishment License bulletin outlining the interim enforcement approach to off-label advertising and sale of rapid antigen tests under workplace screening program 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 12, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Distribution of rapid antigen tests under the workplace screening initiative: Interim enforcement approach From Health Canada 🇨🇦 Information for importing and distributing COVID-19 rapid antigen tests as part of the COVID-19 workplace screening initiative 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 14, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance on equipment for temperature screening in the context of the COVID-19 pandemic From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How equipment for temperature screening is regulated, the limitations of temperature screening for detecting COVID-19 and advice on buying and using these products. 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 July 30, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Screening Tests Prior to Study Enrollment: Guidance for Institutional Review Boards and Clinical Investigators From Food and Drug Administration (FDA) 🇺🇸 An information sheet providing guidance on screening tests for Institutional Review Boards and Clinical Investigators in Good Clinical Practice (GCP). 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 18, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-24162. The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), 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 7, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of the Newborn Screening Test for Severe Combined Immunodeficiency Disorder From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-23496. The Food and Drug Administration (FDA or we) is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part… 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 30, 2017 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 52 of 27/11/2015 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides rules for the registration of in vitro diagnostic products as self-tests for HIV - Human Immunodeficiency Virus, for screening purposes, and makes other provisions. Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on November 27, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-27197. The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified… 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 27, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-33588. The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document… 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 30, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-6621. The Food and Drug Administration (FDA) is proposing to amend the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance… 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 March 23, 2011 Other (Public Domain) 0 reuses 0 favorites
Carrying out rapid tests (point of care tests) to screen for HIV, HCV and HBV infections From National Authority of Medicines and Health Products (Infarmed) 🇵🇹 Entities menu, medical devices area, access to the area with information on rapid screening tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on November 30, 2023 Other (Public Domain) 0 reuses 0 favorites