Identity
- Trade Name
- Amazewell FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- Amazewell™ Semi-Quantitative Ovulation Rapid Test Strip, 25T/Box FDA UDI
- Model / Reference
- AOSS-SQ-25B FDA UDI
- Description
- Amazewell™ Semi-Quantitative Ovulation Rapid Test Strip, 25T/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850054867490 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
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
Yes
FDA UDI
Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Amazewell by Guangzhou Decheng Biotechnology 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.
- Pregmate Ovulation Test Strips (25 Count) — PREGMATE LLC · 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
- Macro & Micro-Test LH Test — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Macro & Micro-Test LH Test — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- CorDx Tyfast — CORETESTS, INC. · Class II
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
- Guangzhou Decheng Biotechnology Co., LTD
Sources (1)
- FDA UDI ff03bc54-a604-41b4-8719-0ce69453a70e 33 fields · synced May 30, 2026