FDA.reportPublic FDA data

Easy@Home FSH Urine Test (5 Tests)

Primary DI
00810038638072
Brand
Easy@Home FSH Urine Test (5 Tests)
Company
EASY HEALTHCARE CORPORATION
Model
EFS1-MA
Catalog number
EFS1-MA-5
Device description
Easy@Home FSH Urine Test (5 Tests)
Published
2025-10-06
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
NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGATest, Follicle Stimulating Hormone (Fsh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810038638079PackageGS1130In Commercial Distribution
00810038638072PrimaryGS10
30810038638073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081003863807910810038638079
00810038638072008100386380728100386380720810038638072
3081003863807330810038638073

GMDN Terms#

Term, Definition table
TermDefinition
Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of follicle stimulating hormone (FSH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility).

Regulatory Flags#

DUNS number
080278407
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810038637327Easy@Home Marijuana Test Cup(1 test kit)ECTH4-114A3ECTH4-114A3-12026-02-12
00810038638157Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
00810038638850Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
10810038638154Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
10810038638857Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
00810038638874Easy@Home Smart Basal ThermometerEBT-300 PINK2025-07-31
00810038638881Easy@Home Smart Basal ThermometerEBT-300 PURPLE2025-07-31
00810038638898Easy@Home Digital Basal ThermometerEBT-018 PINK2025-07-31
00810038638904Easy@Home Digital Basal ThermometerEBT-018 PURPLE2025-07-31
00810038638928Premom Smart Basal ThermometerEBT-3802025-07-31
00810038638935Easy@Home Digital ThermometerEMT-0262025-07-31
00810038638942Easy@Home Rectal Digital ThermometerEMT-0272025-07-31
00810038638959Easy@Home Digital ThermometerEMT-A122025-07-31
00810038638973Premom Smart Basal ThermometerEBT-3802025-07-31
00810038637150easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
00810038638041easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
10810038637157easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
10810038638048easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
00810038638867Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17
10810038638864Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809408864113Surearly SMARTSugentech Inc._Osong BranchNGA2026-05-08
06952062712664Follicle-Stimulating Hormone (FSH) Menopause testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGA2026-03-20
06952062712688Follicle-Stimulating Hormone (FSH) Menopause testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGA2026-03-20
00045611010055SURESIGN™ Menopause (FSH) Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGA2026-01-28
50045611010050SURESIGN™ Menopause (FSH) Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGA2026-01-28
20045611954018EPT Menopause (FSH) Rapid TestHangzhou AllTest Biotech Co., Ltd.NGA2025-12-10
50045611954019EPT Menopause (FSH) Rapid TestHangzhou AllTest Biotech Co., Ltd.NGA2025-12-10
06942598202326One Step FSH Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGA2025-10-10
06942598202333One Step FSH Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGA2025-10-10
06942598202340One Step FSH Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGA2025-10-10
06936983131025One Step One Step FSH Urine test stripHangzhou AllTest Biotech Co., Ltd.NGA2025-08-29
06936983131018One Step FSH Urine midstream TestHangzhou AllTest Biotech Co., Ltd.NGA2025-08-29
86936983131021One Step One Step FSH Urine test stripHangzhou AllTest Biotech Co., Ltd.NGA2025-08-29
00850035206393ProovMfb Fertility, Inc.NGA2025-08-15
00816862027242HORMONElife™WONDFO USA CO., LTD.NGA2025-07-03
10816862027249HORMONElife™WONDFO USA CO., LTD.NGA2025-07-03
08809408863475Surearly SMART Menopause TestSugentech Inc._Osong BranchNGA2025-05-15
08809408863499Surearly SMARTSugentech Inc._Osong BranchNGA2025-05-15
00810143620214GenaCheck® FSH At-Home Menopause TestGenabio Diagnostics Inc.NGA2025-02-26
00850059915370GoldN Easy to Use FSH TestNOVODX CorporationNGA2025-01-24
00816862026078WondfoWONDFO USA CO., LTD.NGA2024-12-24
10816862026075WondfoWONDFO USA CO., LTD.NGA2024-12-24
00860011489153VivooVIVOSENS INC.NGA2024-11-25
10860011489150VivooVIVOSENS INC.NGA2024-11-25
00816862024418BABYLifeWONDFO USA CO., LTD.NGA2024-05-22
10816862024415BABYLifeWONDFO USA CO., LTD.NGA2024-05-22
00633472602245ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGA2023-07-31
10633472602242ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGA2023-07-31
00810038634692One Step FSH Urine Test Strip(10 Tests)EASY HEALTHCARE CORPORATIONNGA2023-07-19
10810038634699One Step FSH Urine Test Strip(10 Tests)EASY HEALTHCARE CORPORATIONNGA2023-07-19