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Optitrol NAT HCV Screening, 10x 1, 2 mL
EUDAMEDClass B (EU MDR)
Ref NT01022Model NT01021
Identity
- Trade Name
- Optitrol NAT HCV Screening, 10x 1,2 mL EUDAMED
- Device Name
- Optitrol NAT HCV Screening, 5x 1,2 mL EUDAMED
- Model / Reference
- NT01021 EUDAMEDNT01022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850075956111 EUDAMED
- Basic UDI-DI
- 0816784020096YG EUDAMED
- EMDN Code
- W0105080808 ALL INFECTIOUS DISEASES CONTROLS - NAT 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 NAT HCV Screening, 10x 1, 2 mL 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 | 0816784020096YG | 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 1eb4dd2b-cd41-455b-8d7f-960605e90e63 61 fields · synced Jul 25, 2026