← Back to catalogue
Isoniazid Determination Kit（Fluorescence Immunochromatographic Assay）
EUDAMEDClass C (EU MDR)
Ref P11418Model 25 tests/box
Identity
- Trade Name
- Isoniazid Determination Kit（Fluorescence Immunochromatographic Assay） EUDAMED
- Device Name
- Isoniazid Determination Kit（Fluorescence Immunochromatographic Assay） EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP11418 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581122 EUDAMED
- Basic UDI-DI
- 697518250P114186H EUDAMED
- Direct Marketing DI
- 06942293581122 EUDAMED
- EMDN Code
- W01020899 THERAPEUTIC DRUG MONITORING - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
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
New Device
Yes
EUDAMED
Isoniazid Determination Kit（Fluorescence Immunochromatographic Assay） by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P114186H | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED d93bb793-3904-415d-8f26-80b6a28e6f2f 61 fields · synced Oct 6, 2026