MicroScan Yeast ID Panel Type
by Beckman Coulter Inc. United States EUDAMED
Ref B1017-70
EMDN W0203010185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-B1017-70E4 | Date9 Jun 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Model / Reference
- B1017-70
- Primary DI / UDI-DI
- D-B1017-70E4
- Basic UDI-DI
- B-B1017-70E4
- EMDN Code
- W0203010185 Antibiotic susceptibility analysers - consumables
- Device Class
- Class IVD General
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000010288
- Authorised representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Other devices from Beckman Coulter, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 6d3cb8d9-ef32-4ad9-a5ff-d20a08b69dc1