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)

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Publisher-reported update

2023-12-02

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.

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