GEXSCOPE® Single Cell RNA Library Kit (Tissue Preservation Solution、Tissue Dissociation Solution、Single Cell RNA Amplification Reagents、Library Reagents 、Barcoding Beads、SCOPE-chip)
by Singleron Biotechnologies Co., LTD. 3 variants
Ref 51800251
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697528560001MJ 69752856000514 | Date25 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- Withdrawn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/IVDR Active
Specification
- Model / Reference
- 51800251
- Primary DI / UDI-DI
- 69752856000514
- Basic UDI-DI
- 697528560001MJ
- EMDN Code
- W01030799 Histology / cytology reagents - other
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000034900
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Singleron Biotechnologies Co., LTD.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No