FDA.reportPublic FDA data

VeriQuick

Primary DI
00049696712682
Brand
VeriQuick
Company
FOURSTAR GROUP INC.
Model
11013002B
Device description
Ovulation Preedictor
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NGETest, Luteinizing Hormone (Lh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00049696712682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00049696712682000496967126820496967126820049696712682

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to varicella-zoster virus (VZV) in a clinical specimen, using a fluorescent immunoassay method.

Regulatory Flags#

DUNS number
656091279
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00049696240482VeriQuick11012450MD2026-04-13
00049696561235B-PURE244203022025-03-28
00049696561587B-PURE244203202025-03-28
00049696187787Bpure64432086A2024-12-10
00049696187794Bpure64432086B2024-12-10
00049696608107Bpure64431638E2024-12-10
00049696608138Bpure64431638EA2024-12-10
00049696608152Bpure64431638EB2024-12-10
00049696712835Bpure644316412024-12-10
00049696122160Thera Plus644103012024-12-05
00049696712675VeriQuick11012637B2024-12-05
00049696719018VeriQuick11012450B2024-12-05
00049696737746VeriQuick11012450MB2021-04-23
00032251056192Family Wellness09037562018-05-14
00032251057663Family Wellness09395042018-05-09
00049696737739VeriQuick11012450MA2021-07-26
00049696736664VeriQuick110126372021-02-09
00049696726030VeriQuick49696726032017-04-27
00049696714297B-PURE244202022024-09-06
00049696714303B-PURE244202022024-09-06

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
00633472602559ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602566ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602573ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
06974464591296One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591302One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591319One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
00381519194696ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-03-23
06952062712657Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
06952062712671Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
00075450847680Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
30075450847681Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
00045611010079SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
50045611010074SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
00860015215826VivooVIVOSENS INC.NGE2026-01-19
00816862028102HORMONElife™WONDFO USA CO., LTD.NGE2025-12-15
00816862028096HORMONElife™WONDFO USA CO., LTD.NGE2025-12-15
10810174471059HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471073HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471097HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
10810174471110HORMONElife™WONDFO USA CO., LTD.NGE2025-12-05
00860014219078VivooVIVOSENS INC.NGE2025-11-28
00860014219085VivooVIVOSENS INC.NGE2025-11-28
20860011489164VivooVIVOSENS INC.NGE2025-11-28
06942598202357One Step LH Ovulation Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGE2025-10-10
06942598202364One Step LH Ovulation Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGE2025-10-10
06942598202371One Step LH Ovulation Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGE2025-10-10