Identity
- Device Name
- APOL1 Genotyping Test EUDAMED
- Model / Reference
- 80-061-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-APOL1_80-061-00TX EUDAMED
- Basic UDI-DI
- B-APOL1_80-061-00TX 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
APOL1 Genotyping Test 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-APOL1_80-061-00TX | 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 d4ab43ca-1156-4809-bd02-dfc4b5cb24b8 61 fields · synced Oct 7, 2026