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Apolipoprotein B Reagent Kit（immunoturbidimetric Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3012531Model R1: 1x50mL, R2: 1x10mLRef 3001049Model Calibration sample: 1×1mLRef 3001729Ref 3021618Ref 3023556Model R1: 1x50mL, R2: 1x10mL，Calibration sample: 1mL
Identity
- Trade Name
- APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Device Name
- APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Model / Reference
- R1: 1x50mL, R2: 1x10mL EUDAMED3012531 EUDAMEDCalibration sample: 1×1mL EUDAMED3001049 EUDAMED3001729 EUDAMED3021618 EUDAMEDR1: 1x50mL, R2: 1x10mL，Calibration sample: 1mL EUDAMED3023556 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261183 EUDAMED06942202261770 EUDAMED06942202247125 EUDAMED06925794593672 EUDAMED06942202215759 EUDAMED
- Basic UDI-DI
- B-06942202261183 EUDAMEDB-06942202261770 EUDAMEDB-06942202247125 EUDAMEDB-06925794593672 EUDAMEDB-06942202215759 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMEDW0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
Apolipoprotein B Reagent Kit（immunoturbidimetric Method） by Dirui Industrial Co., Ltd — 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 Reagent (ApoB 2 x 100) — Beckman Coulter, Inc. · 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
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-06942202261183 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 69f25e73-b4d4-4947-936f-8bb8d897b339 61 fields · synced Aug 2, 2026
- EUDAMED b4b5b28b-3c78-49c7-8c95-d75c14e968d5 61 fields · synced May 17, 2026
- EUDAMED 97edd0ff-a68a-43c1-a3a3-6be386e07742 61 fields · synced May 17, 2026
- EUDAMED 2eb34d73-f0a2-4693-b918-464a40a1642a 61 fields · synced Jul 15, 2026
- EUDAMED 7c2aaa0c-7a11-4a3e-bbae-06a29378af41 61 fields · synced Jul 17, 2026