Identity
- Trade Name
- Signature Select FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Albertsons DPS One Step +/- FDA UDI
- Model / Reference
- One Step Pregnancy Test FDA UDI
- Description
- Albertsons DPS One Step +/- FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00321130352945 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
A comprehensive 2-3 paragraph SEO description written in clear, natural language. This device is a rapid test used to aid detection of pregnancy and predict adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended for self-testing.
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
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
- Better Living Brands Llc
Sources (1)
- FDA UDI 9742f370-8d7c-4994-995f-48b3979440ee 37 fields · synced Jul 26, 2026