Identity
- Trade Name
- Validate FDA UDI
- Generic Name
- Human epididymis protein 4 (HE4) IVD, control FDA UDI
- Device Name
- VALIDATE Tumor Markers 2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: CYFRA 21-1 Set: Cytokeratin 19 Fragment (CYFRA 21-1). HE4 Set: Human Epididymal Protein 4 (HE4). VALIDATE Test Kits are non-automated and intended for laboratory professional use only. FDA UDI
- Model / Reference
- 408re FDA UDI
- Description
- VALIDATE Tumor Markers 2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: CYFRA 21-1 Set: Cytokeratin 19 Fragment (CYFRA 21-1). HE4 Set: Human Epididymal Protein 4 (HE4). VALIDATE Test Kits are non-automated and intended for laboratory professional use only. FDA UDI
Identifiers
- Catalog Number
- 408re FDA UDI
- Primary DI / UDI-DI
- 00850011135716 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Human epididymis protein 4 (HE4) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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: Cytokeratin IVD, controlHuman epididymis protein 4 (HE4) IVD, control
Validate by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI 5d29a961-1649-4e19-aaa5-a7011c03a4b9 37 fields · synced Jun 9, 2026