Carbonic Anhydrase IX Antibody Reagent (Immunohistochemistry)
by Shenzhen Dartmon Biotechnology Co., Ltd.
Ref DMRD0176
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975503520796 | Date26 Jun 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- DMRD0176
- Primary DI / UDI-DI
- 06975503520796, 06975503520826, 06975503520758, 06975503520840, 06975503520765, 06975503520772, 06975503520857, 06975503520802, 06975503520819, 06975503520833, 06975503520789
- Basic UDI-DI
- B-06975503520796, B-06975503520826, B-06975503520758, B-06975503520840, B-06975503520765, B-06975503520772, B-06975503520857, B-06975503520802, B-06975503520819, B-06975503520833, B-06975503520789
- EMDN Code
- W01030709 Primary antisera for immunohistology
- Device Class
- Class IVD General
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000019183
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Shenzhen Dartmon Biotechnology Co., Ltd.
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Properties
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