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Alpha2-Macroglobulin CAL KIT
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 8240400190
by Diagam S.A.
Identity
- Trade Name
- Alpha2-Macroglobulin CAL KIT EUDAMEDFDA UDI
- Generic Name
- Alpha-2-macroglobulin IVD, calibrator FDA UDI
- Device Name
- Alpha2-Macroglobulin CAL KIT EUDAMEDCalibration of Alpha2-Macroglobulin assay on cobas c501/502 systems. FDA UDI
- Model / Reference
- 8240400190 EUDAMED08240400190 FDA UDI
- Description
- Calibration of Alpha2-Macroglobulin assay on cobas c501/502 systems. FDA UDI
Identifiers
- Catalog Number
- 08240400190 FDA UDI
- Primary DI / UDI-DI
- 05415168004770 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05415168004770 EUDAMED
- FDA Product Code
- JIS FDA UDI
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Alpha-2-macroglobulin IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Alpha2-Macroglobulin CAL KIT by Diagam S.A. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05415168004770 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (2)
- EUDAMED 70fd3172-8336-4a50-acb9-5120811151ad 61 fields · synced Jun 19, 2026
- FDA UDI 39ebe769-7185-4bb5-b3f1-dff2acff84c4 35 fields · synced May 30, 2026