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Apolipoprotein B Reagent (ApoB 2 x 100)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 467905
Identity
- Trade Name
- Apolipoprotein B Reagent (ApoB 2 x 100) EUDAMEDSynchron FDA UDI
- Generic Name
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Apolipoprotein B Reagent (ApoB 2 x 100) EUDAMEDFDA UDI
- Model / Reference
- 467905 EUDAMEDFDA UDI
- Description
- Apolipoprotein B Reagent (ApoB 2 x 100) FDA UDI
Identifiers
- Catalog Number
- 467905 FDA UDI
- Primary DI / UDI-DI
- D-467905RM EUDAMED15099590231637 FDA UDI
- Basic UDI-DI
- B-467905RM EUDAMED
- FDA Product Code
- MSJ FDA UDI
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
- GMDN Term
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class IVD General 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
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 B (Apo B) IVD, reagent
Apolipoprotein B Reagent (ApoB 2 x 100) by Beckman Coulter, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
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 (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-467905RM | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 113e1598-2fcc-48f7-b27e-371f59f9ac5c 61 fields · synced Jul 18, 2026
- FDA UDI d8605194-8981-4849-b50a-b48b41a473b6 34 fields · synced May 30, 2026