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EUDAMED last updated this device on Mar 27, 2023
B-00859110005357VALIDATE® GC3 Test Set is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by LGC Clinical Diagnostics, Inc.. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
008591100053571300au(01)00859110005357
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050102UNASSAYED MULTICOMPONENT CONTROLS (CC)W0101050101ASSAYED MULTICOMPONENT CONTROLS (CC)1 warning recorded — scroll inside the panel to see all entries.
US-MF-0000296973822623Primary placement in Ireland; available across 1 country total.
Placed on the market in Ireland; 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 →Certificate health across this manufacturer's portfolio.
3832862CE01AmendedNotified 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 →B-00859110005395On the marketVALIDATE® GC3 Test SetB-00859110005340On the marketVALIDATE® GC3 Test SetB-00859110005401On the marketVALIDATE® GC4 Test SetB-00859110005470On the marketVALIDATE® GC4 Test SetB-00859110005432On the marketVALIDATE® GC4 Test SetB-00859110005487On the marketNo certificate specifically references this device's Basic UDI-DI.