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Aldolase And Glutathione Reductase Level 3 Control (als & Glut Red Control 3)
EUDAMEDFDA 510(k)Class B (EU MDR)
Ref AGR10589
Identity
- Trade Name
- ALDOLASE AND GLUTATHIONE REDUCTASE LEVEL 3 CONTROL (ALS & GLUT RED CONTROL 3) EUDAMED
- Device Name
- ALDOLASE AND GLUTATHIONE REDUCTASE CONTROL EUDAMED
- Model / Reference
- AGR10589 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273218855 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 3 Control (als & Glut Red Control 3) by Randox Laboratories Limited — Class B — FDA_510K, IVDR — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131776 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 50552732BAGRCON157B9 | Class B | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 15f38bb5-3afb-42f5-80d3-f93a34247147 61 fields · synced Oct 5, 2026
- FDA 510(k) K131776 1 fields · synced Jun 9, 2026