- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 8, 2026
B-15060527730219PATHTROL™ VASCULITIS CONTROL is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Eurobio Scientific UK Ltd. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
15060527730219PW880305UK-MF-000053721(01)15060527730219
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Contains human material. The control sera have been tested and found negative for HIV1/2 Ab and HCV Ab, and non- reactive for HBSAg, HBV-DNA, HCV-RNA, HIV-RNA and STS. However, as human source products they should be treated as potentially infectious and handled appropriately.
Refer to ”Materials Safety Data Sheet” for more detailed safety information.
The PathTROL™ Vasculitis Control should not be used beyond the expiry date printed on the tube label and packaging. If there are any signs of microbial contamination or excessive turbidity in the sera, they should be discarded.
The PathTROL™ Vasculitis Control should not be used beyond the expiry date printed on the tube label and packaging. If there are any signs of microbial contamination or excessive turbidity in the sera, they should be discarded.
Sterile
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 Ireland; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | Feb 25, 2019 | Still on market |
| Belgium | Jul 22, 2019 | Still on market |
| Germany | Dec 19, 2023 | Still on market |
| Finland | Dec 9, 2019 | Still on market |
| France | Mar 25, 2019 | Still on market |
| Sweden | Jan 8, 2024 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152011CONTROLS FOR AUTOIMMUNITYPrimary 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 →B-15060527730158On the marketPATHTROL™ TRYPTASE POSITIVE CONTROLB-15060527730141On the marketPATHTROL™ TRYPTASE POSITIVE CONTROLB-25060527730148On the marketPATHTROL™ VASCULITIS CONTROLB-25060527730216On the marketPATHTROL™ VASCULITIS CONTROLB-35060527730213On the marketNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.