Identity
- Trade Name
- femometer FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- Test for luteinizing hormone in urine to predict ovulation date, including meter and test sticks. FDA UDI
- Model / Reference
- FM-IVY-103 FDA UDI
- Description
- Test for luteinizing hormone in urine to predict ovulation date, including meter and test sticks. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972412611836 FDA UDI
- FDA Product Code
- NGE FDA UDI
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1485 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
femometer by Hangzhou Laihe Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing.
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class I
- Pregmate Ovulation Test Strips (25 Count) — PREGMATE LLC · Class I
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class I
- kozekoze — Guangzhou Decheng Biotechnology Co., LTD · Class I
- Wondfo — WONDFO USA CO., LTD. · Class I
- Pregmate 50 Ovulation and 20 Pregnancy Test Strips — PREGMATE LLC · Class I
- Pregmate Ovulation Test Strips (50 Count) — PREGMATE LLC · Class I
- Macro & Micro-Test LH Test — Jiangsu Macro & Micro-Test Med-Tech 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
- Hangzhou Laihe Biotech Co., Ltd.
Sources (1)
- FDA UDI 77eff209-9d9a-48eb-9f66-2302d290d420 33 fields · synced Jun 1, 2026