Identity
- Trade Name
- Walgreens FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical FDA UDI
- Device Name
- Early Result Pregnancy Test (Midstream Format) FDA UDI
- Model / Reference
- 10170 FDA UDI
- Description
- Early Result Pregnancy Test (Midstream Format) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311917198903 FDA UDI
- 510(k) Number
- K172257 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 5.5 Inch FDA UDI
Category: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
Walgreens by Walgreen Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical.
- LEADER — Cardinal Health 110, Inc. · Class II
- LEADER — Cardinal Health 110, Inc. · Class II
- LEADER — Cardinal Health 110, Inc. · Class II
- LEADER — Cardinal Health 110, Inc. · Class II
- Lia Pregnancy Test — Lia Diagnostics · Class II
- Lia Pregnancy Test — Lia Diagnostics · Class II
- LEADER — Cardinal Health 110, Inc. · Class II
- Walgreens — WALGREEN CO. · Class II
Cleared under the same submission
K172257 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 |
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Manufacturer
- Manufacturer
- Walgreen Co.
Sources (1)
- FDA UDI 5220dd66-161c-4983-93f5-9925ead2a88f 36 fields · synced May 30, 2026