Identity
- Trade Name
- HE4 EIA FDA UDI
- Generic Name
- Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 404-10US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350066140326 FDA UDI
- 510(k) Number
- K072939 FDA UDI
- FDA Product Code
- OIU FDA UDI
- GMDN Term
- Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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
Yes
FDA UDI
Category: Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay
He4 Eia by Fujirebio Diagnostics AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Alinity — 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
- Fujirebio Diagnostics AB
Sources (1)
- FDA UDI 5eac764a-1897-482b-9acb-e0471ce48e8f 36 fields · synced Jun 6, 2026