NON-INHABITATIVE BLOOD GLUCOSE METER WITH FALSE PRESENTATION AS ACCU-CHEK via www.kioltech.shop/bg and www.fnastypl.monster From National Organization for Medicines (EOF) ๐ฌ๐ท The EOF draws the attention of consumers to the presentation of the product 'ACCU-CHEK non-invasive glucose glucose meter' with false ... 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 862 Clinical Chemistry and Clinical Toxicology Devices From Food and Drug Administration (FDA) ๐บ๐ธ 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
NON-INVASIVE BLOOD GLUCOSE METER FALSELY REPRESENTED AS MEDTRONIC From National Organization for Medicines (EOF) ๐ฌ๐ท The EOF draws the attention of consumers to the presentation of the product 'non-invasive glucose glucose meter' with the false ... 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 22, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Integrated Continuous Glucose Monitoring System From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2022-03504. The Food and Drug Administration (FDA, Agency, or we) is classifying the integrated continuous glucose monitoring 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 codifiedโฆ 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 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance for the industry and FDA staff on over-the-counter self-monitoring blood glucose test systems. 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 June 25, 2021 Other (Public Domain) 0 reuses 0 favorites
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document by the FDA for the premarket use of blood glucose monitoring test systems in prescription point-of-care settings. 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 January 26, 2021 Other (Public Domain) 0 reuses 0 favorites
Adverse incidents: in vitro diagnostic (IVD) blood glucose meters From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Device-specific guidance for manufacturers on reporting adverse incidents under the vigilance system Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated on December 30, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2019-23471. The Food and Drug Administration (FDA or we) is classifying the continuous glucose monitor data management system into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) willโฆ 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 29, 2019 Other (Public Domain) 0 reuses 0 favorites
Normative Instruction - IN No. 24 of 17/05/2018 From Brazilian Health Regulatory Agency (Anvisa) ๐ง๐ท Provides for the criteria for registration, amendment and revalidation relating to the analytical performance of self-test glucose instruments and their consumables. 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 May 22, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2017-04940. The Food and Drug Administration (FDA) is classifying the continuous glucose monitor secondary display into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for theโฆ 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 14, 2017 Other (Public Domain) 0 reuses 0 favorites
General Office of the General Administration of the blood glucose test strips and other in vitro diagnostic reagents business filed a letter of reply to the relevant issues From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2016-10399 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 30, 2016 Other (Public Domain) 0 reuses 0 favorites
OneTouch Ultra plastic blood glucose strips From National Organization for Medicines (EOF) ๐ฌ๐ท The EOF informs you that the distribution of counterfeit OneTouch Ultraยฎ blood glucose strips by LifeScan has recently been detected.For more information, please contact ... 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 26, 2012 Other (Public Domain) 0 reuses 0 favorites
Notice on the release of guidelines for registration filing information of self-testing blood glucose monitoring system From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2010-10393 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
Fact Sheet on FDA Issues Successive Safety Warnings on Sugar Therapeutics Causing Blood Glucose Monitoring Errors From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2007-10190 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 23, 2007 Other (Public Domain) 0 reuses 0 favorites
On the transmittal of GB/T19634-2005 "in vitro diagnostic test system self-test with blood glucose monitoring system general technical conditions" national standards of the 1st amendment sheet notice From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2006-10128 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 10, 2006 Other (Public Domain) 0 reuses 0 favorites
PMDA Medical Safety Information From Pharmaceuticals and Medical Devices Agency (PMDA) ๐ฏ๐ต Information for Medical Devices. 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites