FDA.reportPublic FDA data

HORMONElife™

Primary DI
00816862027242
Brand
HORMONElife™
Company
WONDFO USA CO., LTD.
Model
W52-S-SQ-6BX
Device description
HORMONElife™ Ultra Accurate FSH Test Strip OTC 6PK
Published
2025-07-03
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
10816862027249PackageGS1160In Commercial Distribution
00816862027242PrimaryGS10
00816862027235Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202724910816862027249
00816862027242008168620272428168620272420816862027242
00816862027235008168620272358168620272350816862027235

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
849098897
Device count
6
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816862027303WELLlife™WCOV-CON-52026-06-01
00816862028416WELLlife™WCOVID-POC-252026-06-01
00816862028294SAFElife™CDOA-L11135A32026-05-15
00816862028324WELLlife™ WFOB-OTC-2BX2026-05-15
00816862028348SAFElife™CDOA-6135F2026-05-15
00816862028362SAFElife™TDOA-6135F2026-05-15
00816862028393SAFElife™WEDDP-1142026-05-15
00816862028249SAFElife™CDOA-12135NT2026-01-15
00816862028270HORMONElife™H1-S-20BG2026-01-15
00816862027723HORMONElife™H1-S-E10-25BX-CLIA2026-01-15
00816862028164SAFElife™CDOA-12135NT2026-01-15
00816862028263HORMONElife™H1-S-20BG2026-01-15
00816862028027SAFElife™CDOA-L111452025-12-15
00816862028089SAFElife™CDOA-L11135A32025-12-15
00816862028102HORMONElife™H2-S-50BG2025-12-15
00816862028157HORMONElife™H1-C-25BX-CLIA2025-12-15
00816862028010SAFElife™CDOA-L111452025-12-15
00816862028072SAFElife™CDOA-L11135A32025-12-15
00816862028096HORMONElife™H2-S-50BG2025-12-15
00816862028119HORMONElife™H1-C-25BX-CLIA2025-12-15

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
00810038638072Easy@Home FSH Urine Test (5 Tests)EASY HEALTHCARE CORPORATIONNGA2025-10-06
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
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