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EUDAMED last updated this device on Aug 6, 2024
B-06438172315020Respiratory Multiplex RT-PCR Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Labsystems Diagnostics Oy. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
064381723150208100533(01)06438172315020
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105040519CORONAVIRUS - NA REAGENTSInactive2 warnings recorded — scroll inside the panel to see all entries.
FI-MF-000018281Primary placement in Finland; available across 1 country total.
Placed on the market in Finland; per-country availability dates not published.
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.
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 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.6438172540I0001R7On the marketNS96 Disc Remover6438172555I0001TROn the marketNS96 Disc Remover6438172555I0001TROn the marketRespiratory Multiplex RT-PCR KitB-06438172315013On the marketVAE- Serum Calibration StandardB-06438172404106On the marketVAE-Control set (High)B-06438172404069On the market