Simplitude ByMe

Primary DI

09349609000204

Basic UDI-DI Code

B-09349609000204

Reference

P002514A1-10

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List A

Status

On The Market

Manufacturer

Atomo Diagnostics Limited

The Simplitude ByMe HIV Self Test is a single-use, immunochromatographic, rapid in-vitro diagnostic test for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV 2) in whole blood. The HIV Self Test is intended to be used by untrained lay users as a self-test to aid in the diagnosis of infection with HIV-1 and HIV-2 from samples of fresh, whole blood obtained through a finger stick blood collection technique. The device requires a sample size of 10 µL.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).