FDA.reportPublic FDA data

GoldN Easy to Use FSH Test

Primary DI
00850059915370
Brand
GoldN Easy to Use FSH Test
Company
NOVODX Corporation
Model
GN011ST02-US
Catalog number
GN011ST
Device description
The GoldN™ Easy to Use FSH Test is a rapid immunochromatographic assay for the qualitative detection of follicle-stimulating hormone (FSH) in urine to aid women in the assessment of the onset of menopause.
Published
2025-01-24
Public version status
Update
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
00850059915370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059915370008500599153708500599153700850059915370

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
Handling Environment Temperature2 Degrees Fahrenheit30 Degrees Fahrenheit
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119046376
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059915882GoldN Easy to Use Vaginal pH TestGN041ST01-USGN041ST2025-01-10
00850059915639GoldN Easy to Use Pregnancy TestGN040ST02-USGN040ST2025-01-07
00850059915646GoldN Easy to Use Ovulation TestGN013ST10-USGN013ST2024-02-22
00850059915424GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC)GN013STGN013ST25-US2024-02-23

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
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
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