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EUDAMED last updated this device on Jun 10, 2026
B-28594036042357ELISA-VIDITEST anti-HHV-6 IgG is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by VIDIA spol. s r.o.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CZ-MF-000036964(01)28594036042357
10 warnings recorded — scroll inside the panel to see all entries.
CW083CW105CW167CW422CW306CW272CW096CW138CW313CW999Sterile
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 Czechia; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| Croatia | — | Still on market |
| Italy | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
28594036042357Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-28594036042357ODZ-235UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105040524HHV-6,7,8 - NA REAGENTSPrimary 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-28594036040025On the marketELISA-VIDITEST anti-EBNA-1 EBV IgMB-08594036040373On the marketELISA-VIDITEST anti-HHV-6 IgGB-18594036042350On the marketELISA-VIDITEST anti-HHV-6 IgGB-08594036042353On the marketELISA-VIDITEST anti-HHV-6 IgG (CSF)B-28594036043446On the marketELISA-VIDITEST anti-HHV-6 IgG (CSF)B-08594036043442On the marketNo 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.No certificate specifically references this device's Basic UDI-DI.