Secondary Antisera
by ScyTek Laboratories Inc. United States EUDAMED
Ref AGL125
EMDN W01030710
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number081010871W01030710F3 | Date7 Dec 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Secondary Antisera
- Model / Reference
- AGL125
- Primary DI / UDI-DI
- 00810108714163
- Basic UDI-DI
- 081010871W01030710F3
- Direct Marketing DI
- 00810108714163
- EMDN Code
- W01030710 Secondary antisera for immunohistology
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED b17654a3-78ac-4529-ba30-15384c0a402a