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IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol FDA UDI
- Generic Name
- Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Estriol unconjugated - IMMULITE - RGT - 100 Tests FDA UDI
- Model / Reference
- 10381168 FDA UDI
- Description
- Estriol unconjugated - IMMULITE - RGT - 100 Tests FDA UDI
Identifiers
- Catalog Number
- LKUE31 FDA UDI
- Primary DI / UDI-DI
- 00630414984452 FDA UDI
- FDA Product Code
- CGI FDA UDI
- GMDN Term
- Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1265 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay.
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- Free Estriol ELISA — DRG International, Inc. · Class I
- Free Estriol — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Free Estriol ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- IMMULITE® 2000 Systems UE3 Unconjugated Estriol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 532888d6-bdc2-4bf0-896e-7b405aae2b17 36 fields · synced May 30, 2026