FDA UDI
In Commercial Distribution
🇺🇸 United States
Vivoo At-Home Urinary Tract Infection Test
DI: 00860011489122
·
Model: VI25V1
·
VIVOSENS INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- Vivoo At-Home Urinary Tract Infection Test
- Primary DI
- 00860011489122
- Version / Model
- VI25V1
- Company Name
- VIVOSENS INC.
- Labeler DUNS
- 086601609
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-11-25
- Public Version
- 2
- Public Version Date
- 2026-02-16
- Public Version Status
- Update
- Public Device Record Key
- 32f4572a-efbd-4491-b984-ad58ea76169f
Device Description
UTI Test
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | 862.1510 | 1 |
| LJX | Test, Urine Leukocyte | Hematology | 864.7675 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65931 | Multiple urine analyte IVD, kit, rapid colorimetric, self-testing | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This test is intended to be used for self-testing by a layperson in the home or similar environment to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00860011489146 | GS1 | Carton | 3 | In Commercial Distribution | |
| Unit of Use | 10860011489129 | GS1 | ||||
| Primary | 00860011489122 | GS1 |
Customer Contacts
- Phone
- +90538376512
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight