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Aldolase Calibration Serum (als Cal)
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref AD5000510(k) K142181
Identity
- Trade Name
- ALDOLASE CALIBRATION SERUM (ALS CAL) EUDAMEDALS CAL FDA UDI
- Generic Name
- Aldolase IVD, calibrator FDA UDI
- Device Name
- ALDOLASE CALIBRATION SERUM EUDAMEDThe Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189. FDA UDI
- Model / Reference
- AD5000 EUDAMEDFDA UDI
- Description
- The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189. FDA UDI
Identifiers
- Catalog Number
- AD5000 FDA UDI
- Primary DI / UDI-DI
- 05055273200089 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BALSCAL0048P EUDAMED
- 510(k) Number
- K142181 FDA UDI
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
- GMDN Term
- Aldolase IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aldolase Calibration Serum (als Cal) by Randox Laboratories Limited — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K142181 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 50552732BALSCAL0048P | Class B | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (3)
- EUDAMED b34b3c74-5be1-4f54-b81a-7e4358aa431b 85 fields · synced Jun 18, 2026
- FDA UDI e8377660-1d37-44da-9aba-935764181af0 37 fields · synced May 30, 2026
- FDA 510(k) K142181 1 fields · synced May 18, 2026