Identity
- Trade Name
- LEADER FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical FDA UDI
- Device Name
- LDR One Step Pregnancy Test 1 ea FDA UDI
- Model / Reference
- 5741855 FDA UDI
- Description
- LDR One Step Pregnancy Test 1 ea FDA UDI
Identifiers
- Catalog Number
- 5741855 FDA UDI
- Primary DI / UDI-DI
- 00096295141511 FDA UDI
- 510(k) Number
- K150022 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
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: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, rapid agglutination, clinical
Leader by Cardinal Health 110, Inc. — 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.
- Walgreens — WALGREEN CO. · Class II
- Lia Pregnancy Test — Lia Diagnostics · Class II
- Lia Pregnancy Test — Lia Diagnostics · Class II
- Walgreens — WALGREEN CO. · Class II
- Walgreens — WALGREEN CO. · Class II
- Walgreens — WALGREEN CO. · Class II
- Walgreens — WALGREEN CO. · Class II
- LEADER — Cardinal Health 110, Inc. · Class II
Cleared under the same submission
K150022 also covers:
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- Family Wellness — FOURSTAR GROUP INC.
- Family Wellness — FOURSTAR GROUP INC.
- VeriQuick — FOURSTAR GROUP INC.
- VeriQuick — FOURSTAR GROUP INC.
- GOODSENSE — GEISS, DESTIN & DUNN, INC
- GOODSENSE — GEISS, DESTIN & DUNN, INC
- Stix — Get Stix Inc.
- Modern Fertility Pregnancy Test — MODERN HEALTH
- Modern Fertility Pregnancy Test — MODERN HEALTH
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
- Cardinal Health 110, Inc.
Sources (1)
- FDA UDI 4ed6baa5-9dc5-4b39-a2b5-09af109f431e 37 fields · synced May 30, 2026