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Test, Follicle Stimulating Hormone (Fsh), Over The Counter
FDA product code NGA · Class 1 · Clinical Chemistry
35
Registered devices
0
Adverse events
2
Recalls
2
510(k) clearances
Devices with this code
Rapid Response — BTNX IncProov — Mfb Fertility, Inc.EPT Menopause (FSH) Rapid Test — Hangzhou AllTest Biotech Co., Ltd.Wondfo — WONDFO USA CO., LTD.HORMONElife™ — WONDFO USA CO., LTD.Clearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHOne Step FSH Rapid Test Dipstick (Urine) — Hangzhou AllTest Biotech Co., Ltd.Dimension Vista® Flex® reagent cartridge FSH — Siemens Healthcare Diagnostics Inc.Follicle-Stimulating Hormone (FSH) Menopause test — ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDProov — Mfb Fertility, Inc.Walgreens — WALGREEN CO.Proov — Mfb Fertility, Inc.One Step FSH Rapid Test Dipstick (Urine) — Hangzhou AllTest Biotech Co., Ltd.Vivoo — VIVOSENS INC.One Step One Step FSH Urine test strip — Hangzhou AllTest Biotech Co., Ltd.Surearly SMART — Sugentech Inc._Osong BranchGoldN Easy to Use FSH Test — NOVODX CorporationProov — Mfb Fertility, Inc.Follicle Stimulating Hormone (FSH) ELISA — DRG International IncFollicle stimulating hormone Rapid Test Strip — ASSURE TECH. (HANGZHOU) CO., LTD.One Step FSH Rapid Test Dipstick (Urine) — Hangzhou AllTest Biotech Co., Ltd.FSH IRMA — Diasource Immunoassays S.A. SAFSH — DRG Instruments Gesellschaft mit beschränkter HaftungOne Step FSH Urine Test Strip(10 Tests) — EASY HEALTHCARE CORPORATION
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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