Identity
- Trade Name
- DBC Pregnenolone ELISA FDA UDI
- Generic Name
- Pregnenolone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the quantitative measurement of Pregnenolone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
- Model / Reference
- CAN-PRE-4500N FDA UDI
- Description
- For the quantitative measurement of Pregnenolone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- CAN-PRE-4500N FDA UDI
- Primary DI / UDI-DI
- B261CANPRE4500N0 FDA UDI
- FDA Product Code
- JNG FDA UDI
- GMDN Term
- Pregnenolone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1615 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
DBC Pregnenolone ELISA by Diagnostics Biochem Canada Inc — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diagnostics Biochem Canada Inc
Sources (2)
- FDA UDI 9663bdd5-30ec-48f3-8234-c7ebbd26381c 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026