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EUDAMED last updated this device on Aug 19, 2024
B-06974849368567Monkeypox Virus Antigen Detection Kit (Immunochromatography) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000012807(01)06974849368567
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This product is a single-use in vitro diagnostic reagent, please do not reuse it, please use it within the validity period.
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 Spain; available across 1 country total.
Placed on the market in Spain; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06974849368567Basic 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-06974849368567HWTS-OT079EUDI 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.
W0105040699VIRAL ANTIGEN/ANTIBODY DETECTION - OTHERPrimary 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.
697484936W0105900101HPOn the marketMacro & Micro-Test Viral DNA/RNA Kit697484936W0105900101HPOn the marketMonkeypox Virus and Typing Nucleic Acid Detection Kit (Fluorescence PCR)B-0000128072010E1NVOn the marketMonkeypox Virus Antigen Detection Kit (Immunochromatography)B-06974849368581On the marketMonkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)B-06974849368604On the marketMonkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)B-06974849368598On the marketCertificate health across this manufacturer's portfolio.
EU-QMS-FI-56762-800162-2026IssuedNotified 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 →