IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Identity
- Trade Name
- IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent EUDAMEDIMMAGE FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent EUDAMEDFDA UDI
- Model / Reference
- 446410 EUDAMEDFDA UDI
- Description
- IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent FDA UDI
Identifiers
- Catalog Number
- 446410 FDA UDI
- Primary DI / UDI-DI
- 15099590223878 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995901446410KM EUDAMED
- FDA Product Code
- MSJ 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Apolipoprotein A-I (Apo A1) IVD, reagent
IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent by Beckman Coulter, Inc. — Class B — FDA_510K, IVDD, IVDR — listed in EUDAMED, FDA GUDID, FDA…
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/IVDD
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964010 | Class B | Active |
| EUDAMED | European Union | CE/IVDD | 150995901446410KM | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 150995901446410KM | Class B | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (3)
- EUDAMED 4817ec46-9d1a-45e9-9703-a102844b16b4 61 fields · synced Jul 9, 2026
- FDA UDI 4e96a783-41de-4871-8ed4-2a2c8e59ad1a 34 fields · synced May 30, 2026
- FDA 510(k) K964010 1 fields · synced May 18, 2026