FDA.reportPublic FDA data

One Step FSH Rapid Test Dipstick (Urine)

Primary DI
06942598202326
Brand
One Step FSH Rapid Test Dipstick (Urine)
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Device description
One Step FSH Rapid Test Dipstick (Urine), 20T/bag; EN/SP
Published
2025-10-10
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
06942598202326PrimaryGS10
86942598202322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942598202326069425982023266942598202326
8694259820232286942598202322

GMDN Terms#

Term, Definition table
TermDefinition
Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinicalA 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 used in the laboratory or in point-of-care analyses as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility). It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
543254717
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936983113793Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)1FHC-A2022026-04-22
06936983113809Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)1FHC-A2022026-04-22
06936983114721Alltest BZO300 Home Rapid Test Panel (Urine)1DBZ-A114H (300ng)2026-04-22
06936983114738Alltest BAR300 Home Rapid Test Panel (Urine)1DBA-A114H (300ng)2026-04-22
06936983114745Alltest AMP500 Home Rapid Test Panel (Urine)1DAM-A114H (500ng)2026-04-22
06936983114752Alltest MOP2000 Home Rapid Test Panel(Urine)1DOP-A114H (2000ng)2026-04-22
06936983114769Alltest MOP300 Home Rapid Test Panel (Urine)1DMO-A114H (300ng)2026-04-22
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)1DMD-A114 (500ng)2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)1DME-A114 (500ng)2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)1DMO-A114 (300ng)2026-04-21
06936983113960Alltest MTD300 Rapid Test Panel (Urine)1DMT-A114 (300ng)2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)1DOP-A114 (2000ng)2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)1DOX-A114 (100ng)2026-04-21
06936983113991Alltest PCP25 Rapid Test Panel (Urine)1DPC-A114 (25ng)2026-04-21
06936983114004Alltest TCA1000 Rapid Test Panel (Urine)1DTC-A114 (1000ng)2026-04-21
06936983114011Alltest THC50 Rapid Test Panel (Urine)1DTH-A114 (50ng)2026-04-21
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)1DAM-A101 (500ng)2026-04-21
06936983114035Alltest BAR300 Rapid Test Dipstick (Urine)1DBA-A101 (300ng)2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)1DBU-A101 (10ng)2026-04-21
06936983114059Alltest BZO300 Rapid Test Dipstick (Urine)1DBZ-A101 (300ng)2026-04-21

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
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
10810038634699One Step FSH Urine Test Strip(10 Tests)EASY HEALTHCARE CORPORATIONNGA2023-07-19