- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Aug 5, 2024
B-06438172309029NeoNat SCID Real-Time 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.
064381723090298100442(01)06438172309029
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0106010299POLYGENETIC DISORDERS TESTS - OTHER4 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.
B-06438172401082On the marketNeoMass CAH System Suitability Mixture (lyophilized)B-06438172401129On the marketNeoMass CAH Tuning Mixture (lyophilized)B-06438172401112On the marketNeoNat SCID Real-Time PCR KitB-06438172309012On the marketNeoNat SCID Real-Time PCR KitB-06438172309036On the marketNeoNat SCID-SMA Multiplex Real-Time PCR KitB-06438172308039On the marketNo 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.