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
Post-market review of HIV nucleic acid tests From Therapeutic Goods Administration (TGA) π¦πΊ Find out more about the post-market review the TGA is undertaking on human immunodeficiency virus (HIV) nucleic acid tests (NATs). 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical performance requirements and risk mitigation strategies for HIV tests From Therapeutic Goods Administration (TGA) π¦πΊ Guidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations. 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
In vitro diagnostic (IVD) medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Links to information on IVD medical devices, including HIV and nutrigenetic tests. 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 June 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Information about HIV tests for home use From Danish Medicines Agency (DKMA) π©π° A document providing guidance on HIV tests for home use. 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 June 27, 2023 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) πΊπΈ Document number 2022-23868. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, postamendments class III devices with the product code MZF, into class II (special controls), subject toβ¦ 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 4, 2022 Other (Public Domain) 0 reuses 0 favorites
ACMD advice on Hepatitis C and Human Immunodeficiency Virus point of care tests From Therapeutic Goods Administration (TGA) π¦πΊ The TGA asked the ACMD to consider acceptable levels of sensitivity and specificity for Hepatitis C (HCV) and Human Immunodeficiency Virus (HIV) PoCTs 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 21, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests From Food and Drug Administration (FDA) πΊπΈ Document number 2022-10461. The Food and Drug Administration (FDA, we, or the Agency) is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments 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 May 16, 2022 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) πΊπΈ Document number 2021-25372. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, a postamendments class III device with the product code MZF, into class II (special controls), subject to premarketβ¦ 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 24, 2021 Other (Public Domain) 0 reuses 0 favorites
HIV self-tests available in Australia From Therapeutic Goods Administration (TGA) π¦πΊ Conditions which placed limitations on the supply of a HIV self-test changed on 22 October 2021 to improve the accessibility of HIV testing. 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, 2021 Other (Non-Commercial) 0 reuses 0 favorites
HIV testing in Australia From Therapeutic Goods Administration (TGA) π¦πΊ Information on the types HIV tests available and guidance for manufacturers and sponsors on clinical performance requirements and risk mitigation strategies for HIV tests supplied in Australia. 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, 2021 Other (Non-Commercial) 0 reuses 0 favorites
HIV point-of-care tests: Conditions of approval for supply in Australia From Therapeutic Goods Administration (TGA) π¦πΊ Update to the conditions of approval on the ARTG for HIV POCT 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 29, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory From Health Canada π¨π¦ 2011 Health Canada guidance document 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 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests From Food and Drug Administration (FDA) πΊπΈ Document number 2020-03515. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices withβ¦ 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, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology From Food and Drug Administration (FDA) πΊπΈ Document number 2020-01725. The Food and Drug Administration (FDA, the Agency, or we) is classifying the human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology into class II (special controls). The special controls that apply to theβ¦ 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 7, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance Document - Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing From Health Canada π¨π¦ Guidance Document: Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing 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 24, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 52 of 27/11/2015 From Brazilian Health Regulatory Agency (Anvisa) π§π· Provides rules for the registration of in vitro diagnostic products as self-tests for HIV - Human Immunodeficiency Virus, for screening purposes, and makes other provisions. Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on November 27, 2015 Other (Public Domain) 0 reuses 0 favorites
HIV Heimtest From National Organization for Medicines (EOF) π¬π· Following information provided by the Austrian authorities on the distribution of self testing kits for the detection of HIV/AIDS in the internet, 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 August 26, 2010 Other (Public Domain) 0 reuses 0 favorites
2002/65/EC: Commission Decision of 25 January 2002 on the national provisions concerning HIV testing kits notified under Article 95(4) of the EC Treaty by the United Kingdom as regards Directive 98/79/EC on in vitro diagnostic medical devices (Text with EEA relevance) (notified under document number C(2002) 297) From European Parliament πͺπΊ Commission Decision on national provisions concerning HIV testing kits notified by the UK under Directive 98/79/EC on in vitro diagnostic medical devices. 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 25, 2002 Creative Commons Attribution 4.0 0 reuses 0 favorites
Carrying out rapid tests (point of care tests) to screen for HIV, HCV and HBV infections From National Authority of Medicines and Health Products (Infarmed) π΅πΉ Entities menu, medical devices area, access to the area with information on rapid screening tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) 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 November 30, 2023 Other (Public Domain) 0 reuses 0 favorites