Identity
- Trade Name
- Walgreens FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Walgreens TPS +/ - Blue Cap FDA UDI
- Model / Reference
- One Step Pregnancy Test FDA UDI
- Description
- Walgreens TPS +/ - Blue Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311917205809 FDA UDI
- 510(k) Number
- K042280 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, 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
No
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
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Walgreens by Walgreen Co. — 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, clinical.
- MGC HEALTH — Guangzhou Decheng Biotechnology Co., LTD · Class II
- First Response Early Result Pregnancy Test — Church & Dwight Co., Inc. · Class II
- Easy@Home Pregnancy Test (8 HCG Midstreams) — EASY HEALTHCARE CORPORATION · Class II
- Oichid — Weihai Kangzhou Biotechnology Engineering Co., Ltd · Class II
- AMPLIM — AMPLIM, LLC · Class II
- Detector hCG — IMMUNOSTICS, INC. · Class II
- UCHECK — SCI Medic, Inc. · Class II
- Rite Aid — RITE AID CORPORATION · Class II
Cleared under the same submission
K042280 also covers:
- Care One — Ahold U.S.A., Inc.
- Discount Drug Mart One Step Pregnancy Test — DISCOUNT DRUG MART, INC.
- Rexall — DOLGENCORP, LLC
- Rexall — DOLGENCORP, LLC
- H.E.B — H. E. BUTT GROCERY COMPANY
- Kroger — KROGER CO., THE
- Kroger — KROGER CO., THE
- Kroger — KROGER CO., THE
- Kroger — KROGER CO., THE
- Meijer — MEIJER, INC.
- Meijer — MEIJER, INC.
- Sunmark Pregnancy Test One Step — Mckesson Corp.
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 c28d3601-6d18-465d-bdff-1671638bafac 36 fields · synced May 30, 2026