Identity
- Trade Name
- a-1-ANTITRYPSIN EUDAMEDAU FDA UDI
- Generic Name
- Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- a-1 ANTITRYPSIN EUDAMEDα-1 ANTITRYPSIN FDA UDI
- Model / Reference
- OSR6163 EUDAMEDFDA UDI
- Description
- α-1 ANTITRYPSIN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590010607 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902OSR6163MW EUDAMED
- 510(k) Number
- K993444 FDA UDI
- FDA Product Code
- DEM FDA UDI
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
- GMDN Term
- Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5130 FDA UDI
- Market of Registration
- 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
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
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
Yes
FDA UDI
a-1-ANTITRYPSIN by Beckman Coulter Ireland Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995902OSR6163MW | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (2)
- EUDAMED 89a44e85-d666-41e5-ad8c-b91b020954f1 61 fields · synced Oct 6, 2026
- FDA UDI 0bcee5b8-a1d7-4a8f-bf08-628716e20b03 34 fields · synced May 30, 2026