Identity
- Trade Name
- Well at Walgreens FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- FPPL Walgreens TPC +/- (ER) FDA UDI
- Model / Reference
- One Step Pregnancy Test FDA UDI
- Description
- FPPL Walgreens TPC +/- (ER) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311917149226 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
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, clinical
A comprehensive medical device review and overview of the Well at Walgreens Total Human Chorionic Gonadotropin IVD, kit, rapid ICT, clinical. Learn about its features, compliance, and more.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Walgreen Co.
Sources (1)
- FDA UDI f07376c4-1db8-47bb-ace2-e4492bdcebd8 36 fields · synced Jul 6, 2026