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Dehydroepiandrosterone (DHEA) ELISA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CAN-DH-490Model 96 Tests
Identity
- Trade Name
- DBC Dehydroepiandrosterone (DHEA) ELISA FDA UDI
- Generic Name
- Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Dehydroepiandrosterone (DHEA) ELISA EUDAMEDFor the quantitative measurement of Dehydroepiandrosterone (DHEA) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
- Model / Reference
- 96 Tests EUDAMEDCAN-DH-490 EUDAMEDFDA UDI
- Description
- For the quantitative measurement of Dehydroepiandrosterone (DHEA) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- CAN-DH-490 FDA UDI
- Primary DI / UDI-DI
- ++B261CANDH490FA EUDAMEDB261CANDH4900 FDA UDI
- Basic UDI-DI
- B-++B261CANDH490FA EUDAMED
- FDA Product Code
- JKC FDA UDI
- EMDN Code
- W0102050102 DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA) EUDAMED
- GMDN Term
- Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1245 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
Dehydroepiandrosterone (DHEA) ELISA by Diagnostics Biochem Canada Inc — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-++B261CANDH490FA | 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 d6ffd7bb-e23a-4685-8b47-d43bb618808a 61 fields · synced Jun 19, 2026
- FDA UDI fd710611-ee3b-45fc-aecf-7d66bc74a722 36 fields · synced May 30, 2026