Identity
- Trade Name
- GenaCheck® FSH At-Home Menopause Test FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing FDA UDI
- Model / Reference
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810143620214 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
Yes
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
GenaCheck® FSH At-Home Menopause Test by Genabio Diagnostics Inc. — 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.
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- 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
- Wondfo — 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
- Genabio Diagnostics Inc.
Sources (1)
- FDA UDI 7323be90-cce1-4bee-9b22-88ed19d6695c 32 fields · synced Jun 8, 2026