ZytoLight SPEC RB1/13q34 Dual Color Probe
Ref Z-2324-200
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-04250380308890 04250380308890 | Date5 May 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- Withdrawn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
- Device Name
- ZytoLight SPEC RB1/13q34 Dual Color Probe
- Model / Reference
- Z-2324-200
- Primary DI / UDI-DI
- 04250380308890
- Basic UDI-DI
- B-04250380308890
- EMDN Code
- W01030703 DNA in situ hybridisation reagents
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000024390
Other devices from ZytoVision GmbH
Properties
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No