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EUDAMED last updated this device on Apr 18, 2024
B-08033622179108LAMBDA LIGHT CHAINS (FREE+BOUND) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by BEN S.R.L. BIOCHEMICAL ENTERPRISE. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08033622179108E05Y0102(01)08033622179108
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102010109KAPPA AND LAMBDA CHAINIT-MF-000021057Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; 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.B-08033622173274On the marketG6PDH-RED CELL LYSING REAGENT (only for automation)803362217VLR0106CNOn the marketKAPPA LIGHT CHAINS (FREE+BOUND)B-08033622179092On the marketOXALATE URINE PURIFIER803362217VLR0105CLOn the marketPLASMAPROTEINS CALIBRATOR 5 concentrationsB-08033622179115On the marketPLASMAPROTEINS ELEVATED CONTROL liquidB-08033622179139On the market