← Back to catalogue
Pregnenolone ELISA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CAN-PRE-4500Model 96 Tests
Identity
- Trade Name
- DBC Pregnenolone ELISA FDA UDI
- Generic Name
- Pregnenolone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pregnenolone ELISA EUDAMEDFor the direct quantitative determination of Pregnenolone by an enzyme immunoassay in human serum. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 96 Tests EUDAMEDCAN-PRE-4500 EUDAMEDFDA UDI
- Description
- For the direct quantitative determination of Pregnenolone by an enzyme immunoassay in human serum. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- CAN-PRE-4500 FDA UDI
- Primary DI / UDI-DI
- ++B261CANPRE45002P EUDAMEDB261CANPRE45000 FDA UDI
- Basic UDI-DI
- B-++B261CANPRE45002P EUDAMED
- FDA Product Code
- JNG FDA UDI
- EMDN Code
- W0102050199 FERTILITY FUNCTION HORMONES - OTHER EUDAMED
- GMDN Term
- Pregnenolone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1615 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
Pregnenolone 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-++B261CANPRE45002P | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostics Biochem Canada Inc.
- EUDAMED SRN
- CA-MF-000032449
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 4b4d3ec1-088f-4236-bc84-645e59c01320 61 fields · synced Jul 23, 2026
- FDA UDI e34f205a-59b9-4664-93b0-7a28d4129f85 36 fields · synced May 30, 2026