Identity
- Trade Name
- Rite Aid FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- RA ONE STEP PREG TST 2CT FDA UDI
- Model / Reference
- 8025004 FDA UDI
- Description
- RA ONE STEP PREG TST 2CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00011822887069 FDA UDI
- 510(k) Number
- K123050 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
No
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
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
Rite Aid by Rite Aid Corporation — 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
- Care One — Ahold U.S.A., Inc. · Class II
Cleared under the same submission
K123050 also covers:
- Clarisse — DELTA BRANDS INC.
- Personal Care — DELTA BRANDS INC.
- Personal Care — DELTA BRANDS INC.
- EGENS — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- EGENS — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- EGENS — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- EGENS — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- EGENS — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- Foster & Thrive — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- Foster & Thrive — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- Good Neighbor — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
- Good Neighbor — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
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
- Rite Aid Corporation
Sources (1)
- FDA UDI f36a1b38-ebae-4d60-aaf5-318c12d75541 34 fields · synced Jun 8, 2026