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17beta-Estradiol Saliva Luminescence Immunoassay
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- 17beta-Estradiol Saliva Luminescence Immunoassay FDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- 17beta-Estradiol Saliva Luminescence Immunoassay - 10 x 96 Determinations FDA UDI
- Model / Reference
- RE62149 FDA UDI
- Description
- 17beta-Estradiol Saliva Luminescence Immunoassay - 10 x 96 Determinations FDA UDI
Identifiers
- Catalog Number
- RE62149 FDA UDI
- Primary DI / UDI-DI
- 04049325012363 FDA UDI
- FDA Product Code
- CHP FDA UDI
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1260 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
17beta-Estradiol Saliva Luminescence Immunoassay by IBL International GmbH — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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
- IBL International GmbH
Sources (2)
- FDA UDI 398ef925-ac73-4431-9674-6bd509281855 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026