Identity
- Trade Name
- CorDx Tyfast FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- CorDx Tyfast Ovulation Test Cassette FDA UDI
- Model / Reference
- ACT21014-21 FDA UDI
- Description
- CorDx Tyfast Ovulation Test Cassette FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042559888 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
CorDx Tyfast by Coretests, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing.
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- Wondfo — WONDFO USA CO., LTD. · Class I
- Pregmate 50 Ovulation and 20 Pregnancy Test Strips — PREGMATE LLC · Class I
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- 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
- Coretests, Inc.
Sources (1)
- FDA UDI 434d78a7-490f-47a3-9553-74d45beac927 33 fields · synced Jun 8, 2026