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EUDAMED last updated this device on Dec 15, 2025
B-06921963715982Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Xiamen Boson Biotech Co., Ltd.. Placed on the EU market in Greece. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
069219637159821N45C5-1CN-MF-000001096(01)06921963715982
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CW010Sterile
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 EL; available across 1 country total.
Placed on the market in EL; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090699OTHER MULTIPLE PATHOGENS - RT & POCPrimary 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 certificate specifically references this device's Basic UDI-DI.
B-1L79ELOn the marketRapid Pregabalin TestB-1L70E2On the marketRapid Rubella IgG/IgM Combo TestB-1N50C2XYOn the marketRapid SARS-CoV-2/Influenza A+B Antigen Duo Test CardB-06921963715913On the marketRapid SARS-CoV-2/Influenza A+B Antigen Duo Test CardB-06921963715357On the marketRapid UR-144 TestB-1L62E3On the marketCertificate health across this manufacturer's portfolio.
V76 061317 0013IssuedNotified 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.
View in glossary →