FDA.reportPublic FDA data

Vivoo

Primary DI
00860015215826
Brand
Vivoo
Company
VIVOSENS INC.
Model
VWHL25V1
Device description
20-Strips HCG Pregnancy Tests, 50-Strips LH-Ovulation Test, and 70 Plastic Urine Cups
Published
2026-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter
NGETest, Luteinizing Hormone (Lh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015215826PrimaryGS10
20860011489164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015215826008600152158268600152158260860015215826
2086001148916420860011489164

GMDN Terms#

Term, Definition table
TermDefinition
Natural conception assistance kitA collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
086601609
Device count
70

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
00860011489122Vivoo At-Home Urinary Tract Infection TestVI25V12024-11-25
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
08809408864113Surearly SMARTSugentech Inc._Osong BranchNGE2026-05-08
08809408864199Surearly SMART Ovulation TestSugentech Inc._Osong BranchNGE2026-05-08
08809408864304Surearly SMART Ovulation Test Starter KitSugentech Inc._Osong BranchNGE2026-05-08
00049696240482VeriQuickFOURSTAR GROUP INC.LCX2026-04-13
00072036734280Harris TeeterHarris Teeter, LLCLCX2026-02-27
00072036734297Harris TeeterHarris Teeter, LLCLCX2026-02-27
00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847666Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847673Hy-Vee® Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847680Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
00195515147545AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00195515147552AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00070552251137Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
00311917083452WalgreensWALGREEN CO.LCX2026-02-05
00311917083513WalgreensWALGREEN CO.LCX2026-02-05
00045611010000SURESIGN™ Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010017SURESIGN™ Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010024SURESIGN™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010031SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010079SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
10810174471059HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471059HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471073HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471073HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471097HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471097HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471110HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471110HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05