PML/RARA Gene Fusion Probe Detection Kit (fluorescence in situ hybridization )
by Wuhan YZY Medical Science and Technology Co., Ltd
Ref IVDD
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-06974604726199 06974604726199 | Date4 Jul 2023 | 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- Withdrawn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
- PML/RARA Gene Fusion Probe Detection Kit (fluorescence in situ hybridization )
- Model / Reference
- IVDD
- Primary DI / UDI-DI
- 06974604726199
- Basic UDI-DI
- B-06974604726199
- EMDN Code
- W0105900102 Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus
- Device Class
- Class IVD General
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000036323
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No