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Optitrol HIV p24, 2x pos, 2.5mL
EUDAMEDClass B (EU MDR)
Ref SR11107Model SR11101
Identity
- Trade Name
- Optitrol HIV p24, 2x pos, 2.5mL EUDAMED
- Device Name
- Optitrol HIVp24 , 4 x 5 mL EUDAMED
- Model / Reference
- SR11101 EUDAMEDSR11107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850075956890 EUDAMED
- Basic UDI-DI
- 0816784020105XQ EUDAMED
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Ireland 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
New Device
Yes
EUDAMED
Optitrol HIV p24, 2x pos, 2.5mL by LGC Clinical Diagnostics, Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0816784020105XQ | Class B | Active |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED aa8f6651-e1ea-494d-b46b-771d9925511d 61 fields · synced Jul 8, 2026