21 CFR Chapter I Subchapter H β Medical Devices β Part 862 Clinical Chemistry and Clinical Toxicology Devices From Food and Drug Administration (FDA) πΊπΈ 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
Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document for industry and FDA staff on molecular diagnostic instruments with combined functions in the premarket stage. 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 March 2, 2020 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) πΊπΈ 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)β¦ 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