Identity
- Trade Name
- Wondfo FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- 1-Midstream; hCG Pregnancy Midstream Test 25 mIU/mL FDA UDI
- Model / Reference
- DW1-M FDA UDI
- Description
- 1-Midstream; hCG Pregnancy Midstream Test 25 mIU/mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816862026801 FDA UDI
- 510(k) Number
- K043443 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Wondfo by Wondfo Usa Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing.
- Equate — Walmart Stores · Class II
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- T Testahead HCG Urine Test Strip — Safecare Biotech (Hangzhou) Co., Ltd. · Class II
- Macro & Micro-Test HCG Pregnancy Test Midstream — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class II
- Equate — Walmart Stores · Class II
- CorDx Tyfast — CORETESTS, INC. · Class II
- CorDx Tyfast — CORETESTS, INC. · Class II
- CorDx Tyfast — CORETESTS, INC. · Class II
Cleared under the same submission
K043443 also covers:
- The Babydust Method — BABYDUST METHOD LLC, THE
- Dealmed — DEALMED MEDICAL SUPPLIES LLC
- Easy@Home Pregnancy Test (10 HCG Midstreams) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (10 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (10 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (100 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (20 HCG strips +20 cups) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (20 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (20 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (25 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (25 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (3 HCG Midstreams) — EASY HEALTHCARE CORPORATION
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 II | Pending data |
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Manufacturer
- Manufacturer
- Wondfo Usa Co., Ltd.
Sources (1)
- FDA UDI 35eafd98-a3a9-4b53-b208-87b8191b758d 36 fields · synced May 30, 2026