TECO® Fungus (1-3)-β-D-Glucan Assay
by TECOmedical AG EUDAMED
Active
Ref TE1068
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-07640146270085 | Date27 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- TECO® Fungus (1-3)-β-D-Glucan Assay
- Model / Reference
- TE1068
- Primary DI / UDI-DI
- 07640146270085
- Basic UDI-DI
- B-07640146270085
- EMDN Code
- W0105060499 Mycology na reagents - other
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000030341
- Authorised representative
- EUROBIO SCIENTIFIC FR-AR-000023178
Other devices from TECOmedical AG
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No