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Alpha2-macroglobulin
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 8240396190
by Diagam S.A.
Identity
- Trade Name
- Alpha2-macroglobulin EUDAMEDFDA UDI
- Generic Name
- Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Alpha2-macroglobulin EUDAMEDQuantitative determination of Alpha2-Macroglobulin in human serum and heparinised plasma on cobas c501/502 systems. FDA UDI
- Model / Reference
- 8240396190 EUDAMED08240396190 FDA UDI
- Description
- Quantitative determination of Alpha2-Macroglobulin in human serum and heparinised plasma on cobas c501/502 systems. FDA UDI
Identifiers
- Catalog Number
- 08240396190 FDA UDI
- Primary DI / UDI-DI
- 05415168003476 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05415168003476 EUDAMED
- FDA Product Code
- DEB FDA UDI
- EMDN Code
- W0102019003 A2-MACROGLOBULIN EUDAMED
- GMDN Term
- Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5620 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
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 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-05415168003476 | 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 57ff6d96-6a5c-4765-9fc5-6f507bb33763 61 fields · synced Jun 18, 2026
- FDA UDI 5aa6e282-856b-419c-87c1-f53981ab5d63 35 fields · synced May 30, 2026