Single-use HIV 1/2 self-test carrying US FDA Breakthrough Device designation. Private at-home testing with rapid result.
| Regulatory Class | IVD Medical Device (MDA) |
|---|
Product Overview
SURE CHECK® HIV is a single-use rapid HIV 1/2 self-test for private, at-home use, carrying US FDA Breakthrough Device designation. Delivers a confidential result from a small finger-prick sample.
Unique Selling Points
- US FDA Breakthrough Device designation — premium trust
- Private, confidential at-home testing
- Simple all-in-one device format
- Detects HIV-1 and HIV-2 antibodies
- Rapid result
Directions for Use
- Read the instructions fully before starting.
- Collect a finger-prick blood sample per the device design.
- Follow the built-in buffer/reading steps.
- Read the result within the stated window; confirm reactive results with laboratory testing and seek counselling.
Specifications
| Targets | HIV-1 & HIV-2 antibodies |
|---|---|
| Specimen | Finger-prick whole blood |
| Format | All-in-one self-test device |
| Designation | US FDA Breakthrough Device |
| Intended use | Self-test |
