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Prolactin (PRL) ELISA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CAN-PRL-4100
Identity
- Trade Name
- DBC Prolactin ELISA FDA UDI
- Generic Name
- Prolactin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Prolactin (PRL) ELISA EUDAMEDFor the quantitative determination of Prolactin in human serum by an enzyme immunoassay. For in vitro diagnostic use. FDA UDI
- Model / Reference
- CAN-PRL-4100 EUDAMEDFDA UDI
- Description
- For the quantitative determination of Prolactin in human serum by an enzyme immunoassay. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- CAN-PRL-4100 FDA UDI
- Primary DI / UDI-DI
- ++B261CANPRL41004G EUDAMEDB261CANPRL41000 FDA UDI
- Basic UDI-DI
- B-++B261CANPRL41004G EUDAMED
- FDA Product Code
- CFT FDA UDI
- EMDN Code
- W0102050108 PROLACTIN EUDAMED
- GMDN Term
- Prolactin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1625 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
No
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
Prolactin (PRL) 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-++B261CANPRL41004G | 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 10de17c0-3b26-43cc-99c8-8c8de41cec3c 61 fields · synced Sep 18, 2026
- FDA UDI 93bca1f3-a94d-4f5e-9095-ffba7012f101 36 fields · synced May 30, 2026