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AutoDELFIA Unconjugated Estriol (uE3) kit
FDA UDIClass I (US FDA UDI)
by Wallac, Inc.
Identity
- Trade Name
- AutoDELFIA Unconjugated Estriol (uE3) kit FDA UDI
- Generic Name
- Free estriol (oestriol) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3). FDA UDI
- Model / Reference
- B083-212 FDA UDI
- Description
- Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3). FDA UDI
Identifiers
- Catalog Number
- B083-212 FDA UDI
- Primary DI / UDI-DI
- 06438147119332 FDA UDI
- FDA Product Code
- CGI FDA UDI
- GMDN Term
- Free estriol (oestriol) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1265 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
No
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
AutoDELFIA Unconjugated Estriol (uE3) kit by Wallac, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Wallac, Inc.
Sources (1)
- FDA UDI 295040f8-7f88-42e7-bb83-8f6ac04d051a 36 fields · synced May 30, 2026