Identity
- Trade Name
- Lumipulse G HE4 Immunoreaction Cartridges FDA UDI
- Generic Name
- Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 234174 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987270234174 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
- Not 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
Lumipulse G HE4 Immunoreaction Cartridges by Fujirebio Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 Inc.
Sources (1)
- FDA UDI 3187e71d-71fb-4361-b805-f3b8cd0e0e6b 36 fields · synced Jun 6, 2026