H-Seq-LR-NGS Sequenzierungskit für 48 Typisierungen
by Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Ref 021Model H-Seq-LR-NGS.m4 Ref 021
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 | Number++G286LongRangeNGS7K +G2860230Z | Date21 Dec 2023 | 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- Withdrawn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
- H-Seq-LR-NGS 48 Typisierungen
- Model / Reference
- H-Seq-LR-NGS.m4 Ref 021, 021
- Primary DI / UDI-DI
- +G2860230Z
- Basic UDI-DI
- ++G286LongRangeNGS7K
- EMDN Code
- W01030403, W0106010401
- Device Class
- Class C
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000018980
Other devices from Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
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