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monogen kit 50 tests
EUDAMEDFDA UDIClass B (EU MDR)
Ref 3000-1001
by Biokit S.A.
Identity
- Trade Name
- monogen kit 50 tests EUDAMEDMonogen 50 TESTS FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination FDA UDI
- Device Name
- Monogen EUDAMED1.4 ml REAGENT 1.0 ml CONTROL + 1.0 ml CONTROL – 9 SLIDES FDA UDI
- Model / Reference
- 3000-1001 EUDAMEDFDA UDI
- Description
- 1.4 ml REAGENT 1.0 ml CONTROL + 1.0 ml CONTROL – 9 SLIDES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950001676 EUDAMEDFDA UDI
- Basic UDI-DI
- 84269500016764Y EUDAMED
- 510(k) Number
- K874678 FDA UDI
- FDA Product Code
- KTN FDA UDI
- EMDN Code
- W0105099003 MONONUCLEOSIS (EBV) - RT & POC EUDAMED
- GMDN Term
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5640 FDA UDI
- Market of Registration
- Spain 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
Yes
EUDAMED
Animal Tissues
Yes
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
New Device
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
monogen kit 50 tests by Biokit, S.a. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 84269500016764Y | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (2)
- EUDAMED f1f13711-5485-4952-b463-5c31076ea2d2 61 fields · synced Jul 26, 2026
- FDA UDI 02e79e16-c8b1-43d3-a2f8-36029834ba58 36 fields · synced May 30, 2026