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EUDAMED last updated this device on May 27, 2026
B-06936155803750One Step Dengue NS1 Ag Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by InTec PRODUCTS, INC.. Placed on the EU market in Greece. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936155803750ITP71003-TC40(01)06936155803750
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105099007DENGUE - RT & POC5 warnings recorded — scroll inside the panel to see all entries.
For professional in vitro diagnostic use only. This test is a screening test used as an aid for diagnosis and all positive results must be confirmed by an alternate method. Results should be interpreted together with clinical information and other diagnostic methods
Read and follow the package insert carefully before use
Treat all specimens as potentially infectious. Wear gloves and protective clothing when handling specimens and autoclave used devices before disposal
Do not use kit materials beyond their expiration dates
OTHER
Primary placement in EL; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ELPrimary placement | — | Still on market |
CN-MF-000023625Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
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 →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 →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.No certificate specifically references this device's Basic UDI-DI.
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