Identity
- Trade Name
- ACCU NEWS Pregnancy Test Midstream FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- 3 pcs/box FDA UDI
- Model / Reference
- Midstream FDA UDI
- Description
- 3 pcs/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042559000 FDA UDI
- 510(k) Number
- K150063 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
Yes
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
ACCU NEWS Pregnancy Test Midstream by Coretests, Inc. — 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
- Wondfo — WONDFO USA CO., LTD. · Class II
- 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
- 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
- Welcheck HCG Urine Test Midstream — Safecare Biotech (Hangzhou) Co., Ltd. · Class II
Cleared under the same submission
K150063 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coretests, Inc.
Sources (1)
- FDA UDI 442aeecd-ab84-47ea-8867-92579fc7bdf7 34 fields · synced Jun 8, 2026