Myogenin Antibody Reagent (Immunohistochemistry)
by Shenzhen Dartmon Biotechnology Co., Ltd.
Ref DMRDB152
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-06927210912968 | 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- Withdrawn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
- DMRDB152
- Primary DI / UDI-DI
- 06927210912968, 06927210913057, 06927210913026, 06927210913019, 06927210912999, 06927210913002, 06927210912951, 06927210912975, 06927210913040, 06927210913033, 06927210912982
- Basic UDI-DI
- B-06927210912968, B-06927210913057, B-06927210913026, B-06927210913019, B-06927210912999, B-06927210913002, B-06927210912951, B-06927210912975, B-06927210913040, B-06927210913033, B-06927210912982
- 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