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Aldolase And Glutathione Reductase Level 2 Control (als & Glut Red Control 2)
EUDAMEDClass B (EU MDR)
Ref AGR10572
Identity
- Trade Name
- ALDOLASE AND GLUTATHIONE REDUCTASE LEVEL 2 CONTROL (ALS & GLUT RED CONTROL 2) EUDAMED
- Device Name
- ALDOLASE AND GLUTATHIONE REDUCTASE CONTROL EUDAMED
- Model / Reference
- AGR10572 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273218848 EUDAMED
- Basic UDI-DI
- 50552732BAGRCON157B9 EUDAMED
- EMDN Code
- W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Aldolase And Glutathione Reductase Level 2 Control (als & Glut Red Control 2) by Randox Laboratories Limited — Class B — IVDR — listed in EUDAMED
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 | 50552732BAGRCON157B9 | Class B | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED a5644987-2c5e-4393-989d-abf0714e9939 61 fields · synced Jun 18, 2026