Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Human epididymis protein 4 (HE4) IVD, calibrator FDA UDI
- Device Name
- Alinity i HE4 Calibrators FDA UDI
- Model / Reference
- 08P5001 FDA UDI
- Description
- Alinity i HE4 Calibrators FDA UDI
Identifiers
- Catalog Number
- 08P5001 FDA UDI
- Primary DI / UDI-DI
- 00380740131067 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Human epididymis protein 4 (HE4) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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 epididymis protein 4 (HE4) IVD, calibrator
Alinity by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human epididymis protein 4 (HE4) IVD, calibrator.
- Elecsys HE4 CalSet — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott · Class II
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
- Abbott
Sources (1)
- FDA UDI f1696113-7156-4766-a2e8-eefc9431f7a7 36 fields · synced May 30, 2026