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INSTI HIV Self Test
Biolytical Laboratories Inc · Model 90-1073 · UDI-DI 00686597201725
0
510(k) clearances
2
Adverse events
0
Recalls
3
Facilities
Description
The INSTI HIV Self Test is a single use, rapid, in vitro diagnostic qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and/or Type 2 (HIV-2) in human fingerstick whole blood. This test is intended for over-the-counter (OTC) consumer use as an aid in the diagnosis of infection with HIV-1 and HIV-2. The test is intended for use as a self test by users 18 years or older. It is not intended to be used with specimens other than fingerstick whole blood.
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