Immunohistology Kits
by ScyTek Laboratories Inc. EUDAMED
Active
Ref EAP500
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number081010871W01030711F5 | Date7 Dec 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Immunohistology Kits
- Model / Reference
- EAP500
- Primary DI / UDI-DI
- 00810108715313
- Basic UDI-DI
- 081010871W01030711F5
- Direct Marketing DI
- 00810108715313
- EMDN Code
- W01030711 Immunohistology kits
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000023816
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from ScyTek Laboratories Inc.
Properties
Show 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