← Back to catalogue
IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent
EUDAMEDClass IVD General (EU MDR)
Ref 447730
Identity
- Trade Name
- IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent EUDAMED
- Device Name
- IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent EUDAMED
- Model / Reference
- 447730 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-447730QL EUDAMED
- Basic UDI-DI
- B-447730QL EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Category: Apolipoprotein B (Apo B) IVD, reagent
IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent by Beckman Coulter, Inc. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Lipoprotein (a) — Diagam S.A. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method) — MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- 5’-Nucleotidase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-447730QL | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (1)
- EUDAMED 47aed48b-fcba-4484-aea9-547b2af638ed 61 fields · synced Jun 18, 2026