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Test, Follicle Stimulating Hormone (Fsh), Over The Counter
FDA product code NGA · Class 1 · Clinical Chemistry
40
Registered devices
0
Adverse events
2
Recalls
2
510(k) clearances
Devices with this code
EPT Menopause (FSH) Rapid Test — Hangzhou AllTest Biotech Co., Ltd.Pregmate — Guangzhou Decheng Biotechnology Co., LTDOne Step FSH Urine Test Strip(10 Tests) — EASY HEALTHCARE CORPORATIONGoldN Easy to Use FSH Test — NOVODX CorporationEasy@Home FSH Urine Test (5 Tests) — EASY HEALTHCARE CORPORATIONBeurer — BEURER NORTH AMERICA, L.P.FSH IRMA — Diasource Immunoassays S.A. SAOne Step FSH Rapid Test Dipstick (Urine) — Hangzhou AllTest Biotech Co., Ltd.Follicle-Stimulating Hormone (FSH) Menopause test — ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDOne Step FSH Urine midstream Test — Hangzhou AllTest Biotech Co., Ltd.GenaCheck® FSH At-Home Menopause Test — Genabio Diagnostics Inc.FSH — DRG Instruments Gesellschaft mit beschränkter HaftungProov — Mfb Fertility, Inc.HORMONElife™ — WONDFO USA CO., LTD.Clearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHSemi-Quantitative Follicle-Stimulating Hormone (FSH) Test Strip — Kunming Lianen Biotechnology Co., LTDOne Step FSH Rapid Test Dipstick (Urine) — Hangzhou AllTest Biotech Co., Ltd.Walgreens — WALGREEN CO.Surearly SMART Menopause Test — Sugentech Inc._Osong BranchDimension Vista® Flex® reagent cartridge FSH — Siemens Healthcare Diagnostics Inc.One Step FSH Rapid Test Dipstick (Urine) — Hangzhou AllTest Biotech Co., Ltd.VeriQuick — FOURSTAR GROUP INC.Follicle-Stimulating Hormone (FSH) Menopause test — ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDFree Estriol — DRG Instruments Gesellschaft mit beschränkter Haftung
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
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