Access Total T3 Calibrators
by Beckman Coulter Inc. EUDAMED
Active
Ref 33835
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number150995901AccTT3Cal7Z | Date2 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- 33835
- Primary DI / UDI-DI
- 15099590227197, 15099590816834
- Basic UDI-DI
- 150995901AccTT3Cal7Z, 150995909AccTT3CalF9
- EMDN Code
- W0102152299 Standards and calibrators - immunochemistry - other
- Device Class
- Class B
- 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
Other properties (7)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No