Pax-5 Antibody Reagent (Immunohistochemistry)
by Shenzhen Dartmon Biotechnology Co., Ltd.
Ref RMB1A093
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-06927210908404 | 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- Withdrawn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
- RMB1A093
- Primary DI / UDI-DI
- 06927210908404, 06927210908411, 06927210908442, 06927210908428, 06927210908459, 06927210908374, 06927210908381, 06927210908398, 06927210908435, 06927210908466, 06927210908367
- Basic UDI-DI
- B-06927210908404, B-06927210908411, B-06927210908442, B-06927210908428, B-06927210908459, B-06927210908374, B-06927210908381, B-06927210908398, B-06927210908435, B-06927210908466, B-06927210908367
- 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