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EUDAMED last updated this device on Mar 15, 2024
B-05904365620130SET OF CONTROL SAMPLES I – SCS I is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List A. Manufactured by Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
PL-MF-0000376421434-IVDD-160/20221434-IVDD-159/2022(01)05904365620130
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.
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.
Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05904365620130Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-05904365620130931UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103030402CONTROL KITS (IMMUNOHAEMATOLOGY)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-05904365620055On the marketReagents for elution The acid glycine, 10% EDTA, 1M TRIS5904365620ELGSOn the marketSET OF CONTROL SAMPLES – SCSB-05904365620123On the marketStandard anti-D (10x2ml)B-05904365620154On the marketStandard anti-D (1x2ml)B-05904365620161On the marketStandard anti-D MIKRO (10x2ml)B-05904365620178On 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.