IMMULITE® 2000 Systems UE3 Unconjugated Estriol
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- IMMULITE 2000 Unconjugated Estriol EUDAMEDIMMULITE® 2000 Systems UE3 Unconjugated Estriol FDA UDI
- Generic Name
- Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol EUDAMEDEstriol unconjugated - IMMULITE - RGT - 200 Tests FDA UDI
- Model / Reference
- IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol EUDAMED10381171 EUDAMED10381192 FDA UDI
- Description
- Estriol unconjugated - IMMULITE - RGT - 200 Tests FDA UDI
Identifiers
- Catalog Number
- L2KUE32 FDA UDI
- Primary DI / UDI-DI
- 00630414971698 EUDAMED00630414997162 FDA UDI
- Basic UDI-DI
- 0405686901473VR EUDAMED
- FDA Product Code
- CGI FDA UDI
- EMDN Code
- W0102050203 UNCONJUGATED (FREE) ESTRIOL EUDAMED
- GMDN Term
- Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1265 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems UE3 Unconjugated Estriol by Siemens Healthcare Diagnostics Products Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI 8cab1684-0f5b-4a23-8e0d-cc99f043c471 36 fields · synced Jul 9, 2026
- EUDAMED 71298e3d-b097-49c3-ab84-332f7e290fac 61 fields · synced Jul 9, 2026