Anti-streptolysin O Reagent Kit(Latex Immunoturbidimetric Assay)
by Dirui Industrial Co., Ltd 8 variants
Ref 3025121
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69422022W0102110401R0LE 06942202229695 | Date20 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 3025121
- Primary DI / UDI-DI
- 06942202229695
- Basic UDI-DI
- 69422022W0102110401R0LE
- EMDN Code
- W01021104 Anti-streptolysin o (quantitative)
- Device Class
- Class B
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000001891
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Dirui Industrial Co., Ltd
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No