Identity
- Trade Name
- Control Kit - GC1ab L5 EUDAMED
- Device Name
- Control Kit - GC1ab L5 EUDAMED
- Model / Reference
- 92-001001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850011135419 EUDAMED
- Basic UDI-DI
- B-00850011135419 EUDAMED
- EMDN Code
- W0101050101,W0101050102 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Control Kit - GC1ab L5 by LGC Clinical Diagnostics, Inc. — 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-00850011135419 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000029697
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 04b1f680-9d38-4652-ba03-4c2085a290c8 61 fields · synced Jun 19, 2026