21 CFR Chapter I Subchapter H – Medical Devices – Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) 🇺🇸 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 – Medical Devices – Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – 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
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-18266. The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target… 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 16, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on informed consent for studies using leftover human specimens, aimed at sponsors, IRBs, and FDA staff. 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 22, 2024 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
Specimen collection swabs From Therapeutic Goods Administration (TGA) 🇦🇺 All collection swabs are medical devices and must be included in the ARTG 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 July 30, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document titled "Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices" that covers topics like labeling, microbiology, 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 April 11, 2019 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-06026. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a… 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 April 1, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganisms and Associated Resistance Marker Nucleic Acids Directly in Respiratory Specimens From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-04719. The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens into class II (special controls). The special controls that apply to the device… 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, 2019 Other (Public Domain) 0 reuses 0 favorites
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-03244. The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an… 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 21, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-22994. The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to… 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 24, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-22287. The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into class II (special controls). The special controls that apply to… 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 16, 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) 🇺🇸 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 class… 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
Medical Devices; Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-25049. The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory… 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 22, 2014 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-20882. The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are… 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 3, 2014 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-12544. The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also… 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 30, 2014 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) 🇺🇸 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 reagents… 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
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-14552. The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is… 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, 2013 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-6518. The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). These… 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 19, 2012 Other (Public Domain) 0 reuses 0 favorites
Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological Assay Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-20115. The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in… 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 9, 2011 Other (Public Domain) 0 reuses 0 favorites