- Role
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- Date of registration
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EUDAMED last updated this device on May 8, 2026
B-FDPCT-402a4EPCT Quantitative Test Kit (Time-Resolved FIA) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhejiang Orient Gene Biotech Co., Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-FDPCT-402a4EFDPCT-402aCN-MF-000017965D-FDPCT-402a4E
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
2 warnings recorded — scroll inside the panel to see all entries.
CW009CW010Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102069013PROCALCITONINPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
V10 092305 0004SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
CR-04-1249-874-25SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
CR-04-1249-875-25IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
B-OGGBDSA-XXXXRX6HOn the marketPCT / IL-6 Quantitative Test Kit (Time-Resolved FIA)B-FDPI-T402a58On the marketPCT ControlB-FDPCT-PN20C6On the marketPCT/CRP ControlB-FDPC-LP3HHOn the marketPCT/CRP Quantitative Test Kit (Time-Resolved FIA)B-FDPC-T402a-G16AFOn the marketPCT/IL-6 ControlB-FDPI-PN209ZOn the marketNo certificate specifically references this device's Basic UDI-DI.