Identity
- Trade Name
- Wondfo FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- 25 Semi-Quantitative FSH Strips; Follicle Stimulating Hormone (FSH) 5/10/25/50 mIU/mL FDA UDI
- Model / Reference
- DW52-S-SQ-25BX FDA UDI
- Description
- 25 Semi-Quantitative FSH Strips; Follicle Stimulating Hormone (FSH) 5/10/25/50 mIU/mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816862026078 FDA UDI
- FDA Product Code
- NGA FDA UDI
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
Wondfo by Wondfo Usa Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing.
- Proov — Mfb Fertility, Inc. · Class I
- GoldN Easy to Use FSH Test — NOVODX Corporation · Class I
- Beurer — BEURER NORTH AMERICA, L.P. · U
- Clearblue — SPD SWISS PRECISION DIAGNOSTICS GMBH · Class I
- One Step FSH Urine Test Strip(10 Tests) — EASY HEALTHCARE CORPORATION · Class I
- Vivoo — VIVOSENS INC · Class I
- GenaCheck® FSH At-Home Menopause Test — Genabio Diagnostics Inc. · Class I
- BABYLife — WONDFO USA CO., LTD. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wondfo Usa Co., Ltd.
Sources (1)
- FDA UDI b28e807a-9dcf-4a19-b982-807778affb1c 35 fields · synced May 31, 2026