| Primary Device ID | 00686597201725 |
| NIH Device Record Key | 67c5734d-f67a-4610-9161-b0abf4a65f50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INSTI HIV Self Test |
| Version Model Number | 90-1073 |
| Catalog Number | 90-1073 |
| Company DUNS | 201060071 |
| Company Name | Biolytical Laboratories Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00686597201725 [Primary] |
| GS1 | 10686597201722 [Package] Package: Box [250 Units] In Commercial Distribution |
| GS1 | 10686597202286 [Package] Package: Box [50 Units] In Commercial Distribution |
| GS1 | 10686597202293 [Package] Package: Box [100 Units] In Commercial Distribution |
| QSS | Hiv Self-Tests |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-03-30 |
| Device Publish Date | 2025-11-19 |
| 00686597201725 - INSTI HIV Self Test | 2026-03-30The 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. |
| 00686597201725 - INSTI HIV Self Test | 2026-03-30 The INSTI HIV Self Test is a single use, rapid, in vitro diagnostic qualitative immunoassay for the detection of antibodies to H |
| 00686597010198 - INSTI HIV-1/HIV-2 Antibody Test | 2020-10-08 Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2) |
| 00686597010303 - INSTI HIV-1 Control Test Kit | 2020-10-08 INSTI HIV-1 Control Test Kit |
| 00686597010310 - INSTI HIV-1/HIV-2 Control Test Kit | 2020-10-08 INSTI HIV-1/HIV-2 Control Test Kit |
| 06865978010376 - INSTI HIV-1/HIV-2 Test Controls | 2018-07-06 INSTI HIV-1/HIV-2 Test Controls |
| 06865978010710 - INSTI Test Controls HIV-1 | 2018-07-06 INSTI Test Controls HIV-1 |
| 06865979010184 - INSTI HIV-1/HIV-2 Antibody Test | 2018-07-06 24 Tests with support materials |
| 06865979010191 - INSTI HIV-1/HIV-2 Antibody Test | 2018-07-06 Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2) |