TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor & Micro
by 3B BlackBio Dx Limited 2 variants
Ref 3B1268
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 | Number89080153043B1267LG 08908015304446 | Date18 Nov 2025 | 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- Withdrawn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
- Device Name
- TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor & Micro
- Model / Reference
- 3B1268
- Primary DI / UDI-DI
- 08908015304446
- Basic UDI-DI
- 89080153043B1267LG
- EMDN Code
- W01060299 Tests for acquired genetic or chromosomal alterations - other
- Device Class
- Class C
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000023698
- Authorised representative
- Wellkang Ltd XI-AR-000001836
From the manufacturer
Manufacturer's product page: NPM1 Mutation Quantitative
Other devices from 3B BlackBio Dx Limited
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No