21 CFR Chapter I Subchapter H โ Medical Devices โ Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) ๐บ๐ธ 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
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) ๐บ๐ธ Guidance document on evaluating performance characteristics of in vitro diagnostic devices for detecting and differentiating influenza viruses. 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 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Seasonal Influenza Rapid Antigen and Combination tests From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance applies to self-tests and point-of-care combo test kits. 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 February 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Seasonal Influenza IVD self-tests From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance on the TGA's expectations concerning clinical performance requirements and risk mitigation for in vitro diagnostic medical devices intended to be used as self-tests for seasonal influenza. 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 18, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2017-00199. The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from classโฆ 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 12, 2017 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2014-11635. The Food and Drug Administration (FDA) is proposing to reclassify antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagentsโฆ 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 May 22, 2014 Other (Public Domain) 0 reuses 0 favorites
General Office of the State Food and Drug Administration on strengthening the medical protective masks, medical protective clothing and other influenza prevention and control of medical devices regulatory work notice From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2013-10116 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 April 8, 2013 Other (Public Domain) 0 reuses 0 favorites
On the release of influenza virus nucleic acid test reagent and other two medical device product registration declaration information guidelines notice From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2012-10002 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 December 23, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of Respiratory Viral Panel Multiplex Nucleic Acid Assay From Food and Drug Administration (FDA) ๐บ๐ธ Document number E9-24432. The Food and Drug Administration (FDA) is announcing the classification of the respiratory viral panel multiplex nucleic acid assay into class II (special controls). The special controls that will apply to the device are three guidance documents entitled: "Class IIโฆ 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 9, 2009 Other (Public Domain) 0 reuses 0 favorites