Identity
- Trade Name
- DBC Testosterone ELISA FDA UDI
- Generic Name
- Total testosterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Testosterone ELISA EUDAMEDFor the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. FDA UDI
- Model / Reference
- CAN-TE-250 EUDAMEDFDA UDI
- Description
- For the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- CAN-TE-250 FDA UDI
- Primary DI / UDI-DI
- ++B261CANTE250KF EUDAMEDB261CANTE2500 FDA UDI
- Basic UDI-DI
- B-++B261CANTE250KF EUDAMED
- 510(k) Number
- K014120 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
- GMDN Term
- Total testosterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1680 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Testosterone 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-++B261CANTE250KF | 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 c01f2f6c-cc01-4389-84bc-d36c8cd3c8b6 61 fields · synced Jul 9, 2026
- FDA UDI cda5de28-634e-4a75-a99e-d12a8f01faae 37 fields · synced May 24, 2026