Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-20895. The Food and Drug Administration (FDA, Agency, or we) is classifying the clozapine test 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 for the clozapine… 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
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-20254. The Food and Drug Administration (FDA, Agency, or we) is classifying the blood collection device for cell-free nucleic acids 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… 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 1 week 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
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-00480. The Food and Drug Administration (FDA, Agency, or we) is classifying the prognostic test for assessment of liver related disease progression into class II (special controls). The special controls that apply to the device type are identified in this order and will be… 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 January 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-05303. The Food and Drug Administration (FDA or we) is classifying the interoperable automated glycemic controller 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 for… 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, 2022 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) 🇺🇸 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 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 February 18, 2022 Other (Public Domain) 0 reuses 0 favorites
ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document by FDA on implementation considerations for FDA-regulated products, focusing on Chemistry, Manufacturing, and Controls (CMC) and Pharmaceutical Quality. 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 September 10, 2021 Other (Public Domain) 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) 🇺🇸 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) will… 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
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Meprobamate Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-23911. The Food and Drug Administration (FDA or we) is classifying the meprobamate test 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 for the meprobamate 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 November 1, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-23912. The Food and Drug Administration (FDA or we) is classifying the insulin therapy adjustment device 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 for the insulin… 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 1, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-27853. The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls)… 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 27, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-24161. The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test 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… 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; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-23491. The Food and Drug Administration (FDA or we) is classifying the acute kidney injury test 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 for the acute… 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
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-22590. The Food and Drug Administration (FDA or we) is classifying the organophosphate test 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 for 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 October 18, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-04941. The Food and Drug Administration (FDA) is classifying the high throughput genomic sequence analyzer for clinical use 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… 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
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display From Food and Drug Administration (FDA) 🇺🇸 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 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 March 14, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-20022. The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c 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 August 25, 2014 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Cardiac Allograft Gene Expression Profiling Test Systems From Food and Drug Administration (FDA) 🇺🇸 Document number E9-25315. The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special… 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 21, 2009 Other (Public Domain) 0 reuses 0 favorites
Clinical Chemistry and Clinical Toxicology Devices; Classification of B-Type Natriuretic Peptide Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 01-4847. The Food and Drug Administration (FDA) is classifying the B- type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for… 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 28, 2001 Other (Public Domain) 0 reuses 0 favorites
Clinical Chemistry Devices; Classification of the Biotinidase Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 00-7541. The Food and Drug Administration (FDA) is classifying the biotinidase test system into class II (special controls). The special control that will apply to this device is restriction to sale, distribution, and use as a prescription device. The agency is taking this action… 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 29, 2000 Other (Public Domain) 0 reuses 0 favorites