| Primary Device ID | 10860011489129 |
| NIH Device Record Key | 8530c11d-0d9c-453c-a0e2-872c881591e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivoo At-Home UTI Test Strips |
| Version Model Number | VI26V2 |
| Company DUNS | 086601609 |
| Company Name | VIVOSENS INC. |
| Device Count | 3 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io | |
| Phone | +1(866) 780-6155 |
| letstalk@vivoo.io |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860015215833 [Primary] |
| GS1 | 10860011489129 [Unit of Use] |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-23 |
| Device Publish Date | 2026-02-13 |
| 10860011489129 - Vivoo At-Home UTI Test Strips | 2026-02-23At-Home UTI Test Strips |
| 10860011489129 - Vivoo At-Home UTI Test Strips | 2026-02-23 At-Home UTI Test Strips |
| 20860011489164 - Vivoo | 2025-12-08 At-Home Ovulation Test |
| 00860011489146 - Vivoo At-Home Urinary Tract Infection Test | 2024-12-03 At-Home Urinary Tract Infection Test |
| 10860011489150 - Vivoo | 2024-12-03 Vivoo FSH Fertility Test (Urine), with 10 products inside. |
| 10860011489167 - Vivoo | 2024-12-03 5-Strip HCG Pregnancy Tests, 25-Strip LH-Ovulation Test, and 30 Plastic Urine Cups |