FDA UDI
In Commercial Distribution
🇺🇸 United States
INSTI HIV Self Test
DI: 00686597201725
·
Model: 90-1073
·
Biolytical Laboratories Inc
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- INSTI HIV Self Test
- Primary DI
- 00686597201725
- Version / Model
- 90-1073
- Catalog Number
- 90-1073
- Company Name
- Biolytical Laboratories Inc
- Labeler DUNS
- 201060071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-19
- Public Version
- 2
- Public Version Date
- 2026-03-30
- Public Version Status
- Update
- Public Device Record Key
- 67c5734d-f67a-4610-9161-b0abf4a65f50
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QSS | Hiv Self-Tests | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65848 | HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00686597201725 | GS1 | ||||
| Package | 10686597201722 | GS1 | Box | 250 | In Commercial Distribution | |
| Package | 10686597202286 | GS1 | Box | 50 | In Commercial Distribution | |
| Package | 10686597202293 | GS1 | Box | 100 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BP251179 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius