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OI-genomic profiling assay
EUDAMEDClass IVD General (EU MDR)
Ref OI-GPAModel OI-genomic profiling assay
Identity
- Trade Name
- OI-genomic profiling assay EUDAMED
- Device Name
- OI-genomic profiling assay EUDAMED
- Model / Reference
- OI-genomic profiling assay EUDAMEDOI-GPA EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-US-MF-000017722U2 EUDAMED
- Basic UDI-DI
- B-US-MF-000017722U2 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
OI-genomic profiling assay by Laboratory Corporation of America Holdings — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-US-MF-000017722U2 | Class IVD General | Active |
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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 0b576b81-a1d4-4705-9150-12400222d1ad 61 fields · synced Oct 6, 2026