← Back to catalogue
Isoniazid CLIA Kit（Chemiluminescence Immunoassay）
EUDAMEDClass C (EU MDR)
Ref F11450Model 100 tests/box
Identity
- Trade Name
- Isoniazid CLIA Kit（Chemiluminescence Immunoassay） EUDAMED
- Device Name
- Isoniazid CLIA Kit（Chemiluminescence Immunoassay） EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF11450 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590704 EUDAMED
- Basic UDI-DI
- 697518250F114502B EUDAMED
- Direct Marketing DI
- 06942293590704 EUDAMED
- EMDN Code
- W01020899 THERAPEUTIC DRUG MONITORING - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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 CLIA Kit（Chemiluminescence Immunoassay） 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 | 697518250F114502B | 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 7afd29ed-73a6-4b00-86b4-01d24e41862b 61 fields · synced Jun 18, 2026