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Apolipoprotein A Reagent (ApoA 2 x 100)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 467900
Identity
- Trade Name
- Apolipoprotein A Reagent (ApoA 2 x 100) EUDAMEDSynchron FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Apolipoprotein A Reagent (ApoA 2 x 100) EUDAMEDFDA UDI
- Model / Reference
- 467900 EUDAMEDFDA UDI
- Description
- Apolipoprotein A Reagent (ApoA 2 x 100) FDA UDI
Identifiers
- Catalog Number
- 467900 FDA UDI
- Primary DI / UDI-DI
- D-467900RB EUDAMED15099590229931 FDA UDI
- Basic UDI-DI
- B-467900RB 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 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 A-I (Apo A1) IVD, reagent
Apolipoprotein A Reagent (ApoA 2 x 100) by Beckman Coulter, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.
- APOLIPOPROTEÍNA A1 — QUIMICA CLINICA APLICADA S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Nephstar Apo A1 Kit — Goldsite Diagnostics Inc. · IVD General
- APO A1 — Medicon Hellas SA · IVD General
- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- Apolipoprotein A1 — Diagam S.A. · IVD General
- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL 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-467900RB | 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 7951c102-aa07-43fa-a2c8-afc0b4c93169 61 fields · synced Jun 19, 2026
- FDA UDI 50d3c760-69a5-4eb4-b5d6-ee0b0bf7e2fa 34 fields · synced May 30, 2026