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EUDAMED last updated this device on Jun 28, 2024
570057R0801P3011A040100QMGenetiSure Dx Hybridization Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Agilent Technologies, Inc.. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05700571112625K1201-64200(01)05700571112625
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHERUS-MF-000009385The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Denmark; available across 1 country total.
Placed on the market in Denmark; 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.5700570000000000A0302016AOn the marketEpoch 25700570000000000A0302016AOn the marketGenetiSure Dx Cot-1 Human DNA570057R0801P3011A040100QMOn the marketGenetiSure Dx Labeling Kit570057R0801P3011A040100QMOn the marketGenetiSure Dx Labeling Kit Purification Columns570057R0801P3011A040100QMOn the marketGenetiSure Dx Postnatal Assay570057R0403P3011C040000N8On the market