Description:
Mylan HIV Self-Test is a single-use, immunochromatographic, rapid in-vitro diagnostic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in whole blood.
The Mylan HIV Self Test is intended to be used by untrained lay users in a private setting 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 10uL. The test result is qualitative (“your test is positive” or “your test is negative”) and not for screening blood donors.”