Identity
- Trade Name
- APO A1 EUDAMEDAU FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- APO A1 EUDAMEDFDA UDI
- Model / Reference
- OSR6142 EUDAMEDFDA UDI
- Description
- APO A1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590010393 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995901OSR6142M3 EUDAMED
- 510(k) Number
- K952425 FDA UDI
- FDA Product Code
- JHN FDA UDI
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMED
- GMDN Term
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1475 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
Category: Apolipoprotein A-I (Apo A1) IVD, reagent
Apo A1 by Beckman Coulter, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.
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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 | 150995901OSR6142M3 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (2)
- EUDAMED 506858f5-1b1f-4854-a7c2-20fd05f44b4b 61 fields · synced Aug 2, 2026
- FDA UDI 6f256159-d6c7-4f67-ae00-2f146ebf15fc 34 fields · synced May 29, 2026