FDA.reportPublic FDA data

Vivoo At-Home Urinary Tract Infection Test

Primary DI
00860011489122
Brand
Vivoo At-Home Urinary Tract Infection Test
Company
VIVOSENS INC.
Model
VI25V1
Device description
UTI Test
Published
2024-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011489146PackageGS13In Commercial Distribution
00860011489122PrimaryGS10
10860011489129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011489146008600114891468600114891460860011489146
00860011489122008600114891228600114891220860011489122
1086001148912910860011489129

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, self-testingA 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].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+90538376512letstalk@vivoo.io

Regulatory Flags#

DUNS number
086601609
Device count
3

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015215833Vivoo At-Home UTI Test StripsVI26V22026-02-13
10860011489129Vivoo At-Home UTI Test StripsVI26V22026-02-13
00860015215826VivooVWHL25V12026-01-19
00860014219078Vivoov22025-11-28
00860014219085VivooVWHL50-v22025-11-28
20860011489164VivooVWHL50-v22025-11-28
00860011489153VivooVWHF25V12024-11-25
00860011489160VivooVWHL25V12024-11-25
00860011489146Vivoo At-Home Urinary Tract Infection TestVI25V12024-11-25
10860011489150VivooVWHF25V12024-11-25
10860011489167VivooVWHL25V12024-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.JMT2026-04-15
16936983186893DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-14
16936983192887Alltest Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192894Alltest Multi-Drug 16 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192900Alltest Multi-Drug 18 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197257Multi-Drug 8 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197264Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197271Multi-Drug 14 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13