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PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3)
EUDAMEDFDA UDIClass C (EU MDR)
Ref PE10529
Identity
- Trade Name
- PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3) EUDAMEDPRE-ECLAMPSIA CONTROL LEVEL 3 FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- PRE-ECLAMPSIA CONTROL EUDAMEDThe Pre eclampsia Control Level 3 is intended for use with in vitro diagnostic assays for the quantitative determination of placental growth factor (PlGF) and soluble fms like tyrosine kinase 1 (sFlt 1) in human serum and plasma. The Pre eclampsia Control Level 3 is assayed with target values and are suitable for use on various analysers. The Pre eclampsia Control Level 3 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI
- Model / Reference
- PE10529 EUDAMEDFDA UDI
- Description
- The Pre eclampsia Control Level 3 is intended for use with in vitro diagnostic assays for the quantitative determination of placental growth factor (PlGF) and soluble fms like tyrosine kinase 1 (sFlt 1) in human serum and plasma. The Pre eclampsia Control Level 3 is assayed with target values and are suitable for use on various analysers. The Pre eclampsia Control Level 3 is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Identifiers
- Catalog Number
- PE10529 FDA UDI
- Primary DI / UDI-DI
- 05055273218992 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732CPREECL063JH EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMED
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Northern 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
Yes
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
New Device
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3) by Randox Laboratories Limited — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50552732CPREECL063JH | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 7051c006-162d-4ff1-8194-81ae36284cb7 61 fields · synced Jul 15, 2026
- FDA UDI be80307c-43a3-4af3-8c22-d36dfe63c9cf 36 fields · synced May 30, 2026