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Estrone ELISA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CAN-E-420Model 96 Tests
Identity
- Trade Name
- DBC Estrone ELISA FDA UDI
- Generic Name
- Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Estrone ELISA EUDAMEDFor the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
- Model / Reference
- 96 Tests EUDAMEDCAN-E-420 EUDAMEDFDA UDI
- Description
- For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- CAN-E-420 FDA UDI
- Primary DI / UDI-DI
- ++B261CANE420DB EUDAMEDB261CANE4200 FDA UDI
- Basic UDI-DI
- B-++B261CANE420DB EUDAMED
- FDA Product Code
- CGF FDA UDI
- EMDN Code
- W0102050204 ESTRONE EUDAMED
- GMDN Term
- Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1280 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Estrone ELISA by Diagnostics Biochem Canada Inc — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-++B261CANE420DB | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Diagnostics Biochem Canada Inc.
- EUDAMED SRN
- CA-MF-000032449
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 1ebb435c-74ef-4448-80a6-91f18889afc3 61 fields · synced Jun 8, 2026
- FDA UDI b9454bef-4961-4538-9a8e-766d3e009c71 36 fields · synced May 30, 2026