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
The purpose of this guidance document is to provide manufacturers of Class IV Human Immunodeficiency Virus (HIV) rapid diagnostic tests (RDTs) intended to be used at the point of care (POC) and/or for self-testing (home testing) with specific recommendations on: (1) the analytical and clinical data, and (2) device labelling, required to support a medical device licence application.
- Publisher
- Health Canada
- Resources
- 2
- Catalogue metadata updated
- 2023-12-02
Data overview
- Formats
- HTML
- File languages
- English, French
Official sources and licences
Resources
- 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 (English, HTML) HTML
- 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 (French, HTML) HTML