Identity
- Trade Name
- FAMILY WELLNESS FDA UDI
- Generic Name
- Human chorionic gonadotropin alpha-subunit IVD, calibrator FDA UDI
- Device Name
- FW FIRST SIGNAL PREG TEST 2CT FDA UDI
- Model / Reference
- SKU939756 FDA UDI
- Description
- FW FIRST SIGNAL PREG TEST 2CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00032251689659 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Human chorionic gonadotropin alpha-subunit IVD, calibrator 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
No
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: Human chorionic gonadotropin alpha-subunit IVD, calibrator
Family Wellness by Family Dollar Stores — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human chorionic gonadotropin alpha-subunit IVD, calibrator.
- sunmark — NANTONG EGENS BIOLOGY TECHNIC CO., LTD. · Class II
- RITE AID — NANTONG EGENS BIOLOGY TECHNIC CO., LTD. · Class II
- EGENS — NANTONG EGENS BIOLOGY TECHNIC CO., LTD. · Class II
- RITE AID — NANTONG EGENS BIOLOGY TECHNIC CO., LTD. · Class II
- One + Step — NANTONG EGENS BIOLOGY TECHNIC CO., LTD. · Class II
- PARAID — NANTONG EGENS BIOLOGY TECHNIC CO., LTD. · Class II
- Good Neighbor — NANTONG EGENS BIOLOGY TECHNIC CO., LTD. · Class II
- EGENS — NANTONG EGENS BIOLOGY TECHNIC CO., LTD. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Family Dollar Stores
Sources (1)
- FDA UDI d0d74350-6f1e-4533-a066-961e78479bff 33 fields · synced Jun 8, 2026