FDA.reportPublic FDA data

One Step FSH Urine Test Strip(10 Tests)

Primary DI
10810038634699
Brand
One Step FSH Urine Test Strip(10 Tests)
Company
EASY HEALTHCARE CORPORATION
Model
EFS1-S
Catalog number
RH-FSH-S10
Device description
One Step FSH Urine Test Strip(10 Tests)
Published
2023-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10810038634699PackageGS1250In Commercial Distribution
00810038634692PrimaryGS10
30810038634693Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081003863469910810038634699
00810038634692008100386346928100386346920810038634692
3081003863469330810038634693

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080278407
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810038638072Easy@Home FSH Urine Test (5 Tests)EFS1-MAEFS1-MA-52025-10-06
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

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
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