Anti-histone Antibody Chemiluminescent Immunoassay Kit
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref IM4411264Model IM4410264 IM4411264 IM4414264 IM4415264
EMDN W0102100107
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number69506174IM441264DX | Date28 Apr 2026 | StatusActive |
| European Union | CE/IVDR | Number69506174IM441264DX | Date28 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Device Name
- Anti-histone Antibody Chemiluminescent Immunoassay Kit
- Model / Reference
- IM4410264 IM4411264 IM4414264 IM4415264, IM4411264
- Primary DI / UDI-DI
- 06950617403074, D-IM4411264J6
- Basic UDI-DI
- 69506174IM441264DX, B-IM4411264J6
- Direct Marketing DI
- 06950617403074
- EMDN Code
- W0102100107 Histones (h1, h2a, h3, h4,…hn)
- Device Class
- Class BClass IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Maccura Biotechnology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED fd60043c-759d-411f-a95d-091c5332e44c
- EUDAMED D-IM4411264J6|B-IM4411264J6