← Back to catalogue
TruSight Oncology 500 LDT Assay (TS0500)
EUDAMEDClass IVD General (EU MDR)
Ref TSO500LDT
Identity
- Device Name
- TruSight Oncology 500 LDT Assay (TS0500) EUDAMED
- Model / Reference
- TSO500LDT EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TSO500LDTJF EUDAMED
- Basic UDI-DI
- B-TSO500LDTJF EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
TruSight Oncology 500 LDT Assay (TS0500) by Laboratory Corporation of America Holdings — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-TSO500LDTJF | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laboratory Corporation of America Holdings
- EUDAMED SRN
- US-MF-000017722
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 5b0cbee4-b48c-414d-ac7b-534bde1f9f98 61 fields · synced Oct 6, 2026