Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Human epididymis protein 4 (HE4) IVD, control FDA UDI
- Device Name
- ARCHITECT HE4 Controls FDA UDI
- Model / Reference
- 2P54-10 FDA UDI
- Description
- ARCHITECT HE4 Controls FDA UDI
Identifiers
- Catalog Number
- 02P5410 FDA UDI
- Primary DI / UDI-DI
- 00380740003982 FDA UDI
- FDA Product Code
- OIU FDA UDIJIT FDA UDIJJX FDA UDI
- GMDN Term
- Human epididymis protein 4 (HE4) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 FDA UDI862.1150 FDA UDI862.1660 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
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 epididymis protein 4 (HE4) IVD, control
Architect 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, control.
- HE4 Control Slides — BIO SB, INC. · Class I
- PreciControl HE4 — Roche Diagnostics Corp. · Class I
- HE4 control slides — BIO SB, INC. · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Alinity — Abbott · Class I
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 ffa9c215-c09b-474e-9b4a-be2270dae598 36 fields · synced May 30, 2026