21 CFR Chapter I Subchapter H β Medical Devices β Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) πΊπΈ 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 β Medical Devices β Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 809 In Vitro Diagnostic Products for Human Use From Food and Drug Administration (FDA) πΊπΈ Regulation on in vitro diagnostic products for human use under 21 CFR Chapter I Subchapter H - Medical Devices - Part 809. 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 July 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Conformity assessment procedures for immunohaematology reagents From Therapeutic Goods Administration (TGA) π¦πΊ This guidance outlines ARTG and conformity assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know. 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 June 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
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
Notice on Matters Relating to Changes in Product Specifications of Some In Vitro Diagnostic Reagents by the Comprehensive Department of the State Drug Administration (SDA) From National Medical Products Administration (NMPA) π¨π³ FGWJ-2023-10001 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 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for the industry and FDA staff regarding the replacement reagent and instrument family policy for in vitro diagnostic devices. 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 August 16, 2022 Other (Public Domain) 0 reuses 0 favorites
Notice of the Comprehensive Department of the State Drug Administration on Improving the Quality and Safety Supervision of New Coronavirus Antigen Detection Reagents From National Medical Products Administration (NMPA) π¨π³ FGWJ-2022-120 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 12, 2022 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents From Food and Drug Administration (FDA) πΊπΈ This document is a Compliance Policy Guide (CPG) titled "Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents". 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 July 31, 2020 Other (Public Domain) 0 reuses 0 favorites
Notice of the Comprehensive Department of the State Drug Administration on Cracking Down on the Illegal Manufacture and Sale of New Crown Pneumonia Virus Test Reagents From National Medical Products Administration (NMPA) π¨π³ FGWJ-2020-10001 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
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff". It covers topics such as Good Clinical Practice (GCP) and Premarket. 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 February 28, 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
Amendment to the Administrative Measures for the Registration of In Vitro Diagnostic Reagents (State Food and Drug Administration Decree No. 30) From National Medical Products Administration (NMPA) π¨π³ FGWJ-2017-10098 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 8, 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) πΊπΈ 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 classβ¦ 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
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) π¨π³ 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
General Office of the General Administration of the in vitro diagnostic reagents on in vitro diagnostic reagents instructions textual changes related to the issue of notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2016-10365 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 5, 2016 Other (Public Domain) 0 reuses 0 favorites
CIRCULAR 8/16 From National Administration of Drugs, Food and Medical Devices (ANMAT) π¦π· Affidavit of Annual Maintenance of Diagnostic Reagents 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 January 1, 2016 Creative Commons Attribution 4.0 0 reuses 0 favorites
Reply Letter from the General Office of the Food and Drug Administration on Issues Related to the Operation of In Vitro Diagnostic Reagents From National Medical Products Administration (NMPA) π¨π³ FGWJ-2015-10524 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 October 22, 2015 Other (Public Domain) 0 reuses 0 favorites
Circular of the General Office of the Food and Drug Administration on the Issuance of the Work Program for Quality Assessment and Comprehensive Management of In Vitro Diagnostic Reagents From National Medical Products Administration (NMPA) π¨π³ FGWJ-2015-10105 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 7, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents From Food and Drug Administration (FDA) πΊπΈ Document number 2014-21479. The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to 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 September 10, 2014 Other (Public Domain) 0 reuses 0 favorites