Alinity c Lp(a) Control Kit
EUDAMEDFDA UDIClass B (EU MDR)
by Biokit S.A.
Identity
- Trade Name
- Alinity c Lp(a) Control Kit EUDAMEDAlinity FDA UDI
- Generic Name
- Lipoprotein A IVD, control FDA UDI
- Device Name
- Alinity c Lp(a) Reagent Kit EUDAMEDAlinity c Lp(a) Control Kit FDA UDI
- Model / Reference
- 01R1410 EUDAMEDFDA UDI
- Description
- Alinity c Lp(a) Control Kit FDA UDI
Identifiers
- Catalog Number
- 01R1410 FDA UDI
- Primary DI / UDI-DI
- 00380740153823 EUDAMEDFDA UDI
- Basic UDI-DI
- 8436003070467XU EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) EUDAMED
- GMDN Term
- Lipoprotein A IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Apolipoprotein B (Apo B) IVD, reagent
Alinity c Lp(a) Control Kit by Biokit, S.a. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8436003070467XU | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (2)
- EUDAMED ee48cece-fca5-484a-9a13-fa1a1eec5cb2 61 fields · synced Jul 11, 2026
- FDA UDI c5f34592-658b-4b60-a93a-8e30ff0306cc 36 fields · synced May 30, 2026