Identity
- Trade Name
- LEADER FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, reagent FDA UDI
- Device Name
- LDR Pregnancy Test Analog 1 ea FDA UDI
- Model / Reference
- 5402771 FDA UDI
- Description
- LDR Pregnancy Test Analog 1 ea FDA UDI
Identifiers
- Catalog Number
- 5402771 FDA UDI
- Primary DI / UDI-DI
- 00096295133219 FDA UDI
- 510(k) Number
- K062703 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, reagent 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, reagent
Leader by Cardinal Health 110, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062703 also covers:
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
- Cardinal Health 110, Inc.
Sources (1)
- FDA UDI fe7ff57d-473b-4e4d-bfac-c647bd0d141d 36 fields · synced May 31, 2026