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Follicle Stimulating Hormone (FSH) ELISA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CAN-FSH-4060Model 96 Tests
Identity
- Trade Name
- DBC Follicle Stimulating Hormone (FSH) ELISA FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Follicle Stimulating Hormone (FSH) ELISA EUDAMEDFor the quantitative measurement of Follicle Stimulating Hormone (FSH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
- Model / Reference
- 96 Tests EUDAMEDCAN-FSH-4060 EUDAMEDFDA UDI
- Description
- For the quantitative measurement of Follicle Stimulating Hormone (FSH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- CAN-FSH-4060 FDA UDI
- Primary DI / UDI-DI
- ++B261CANFSH4060WH EUDAMEDB261CANFSH40600 FDA UDI
- Basic UDI-DI
- B-++B261CANFSH4060WH EUDAMED
- FDA Product Code
- CGJ FDA UDI
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1300 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
Follicle Stimulating Hormone (FSH) 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-++B261CANFSH4060WH | 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 3d6133a3-2c3c-41d3-9fe9-8383325f7f8a 61 fields · synced Jun 18, 2026
- FDA UDI f26b89bc-1ebb-4cb6-ba21-3d1e9bee6b59 36 fields · synced May 30, 2026