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Vivoo At-Home Urinary Tract Infection Test

FDA UDI

Class I (US FDA UDI)

by Vivosens Inc

Identity

Trade Name
Vivoo At-Home Urinary Tract Infection Test FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, self-testing FDA UDI
Device Name
At-Home Urinary Tract Infection Test FDA UDI
Model / Reference
VI25V1 FDA UDI
Description
At-Home Urinary Tract Infection Test FDA UDI

Identifiers

Primary DI / UDI-DI
00860011489122 FDA UDI
FDA Product Code
JMT FDA UDI
LJX FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, self-testing FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1510 FDA UDI
864.7675 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple urine analyte IVD, kit, rapid colorimetric, self-testing

Vivoo At-Home Urinary Tract Infection Test by Vivosens Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, self-testing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vivosens Inc

Sources (1)

  • FDA UDI 32f4572a-efbd-4491-b984-ad58ea76169f 35 fields · synced Jun 8, 2026