- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jan 18, 2025
B-04250861815541Anti-Fyb for card method, Coombs-reactive, polyclonal, human is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by ANTITOXIN GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0425086181554102.183-03(01)04250861815541
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103030501OTHER ANTIGEN TYPING REAGENTSDE-MF-000008156D1052200083Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; 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 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-04250861803319On the marketAnti-Fyb Coombs-reactive, polyclonal, humanB-04250861803210On the marketAnti-Fyb for card method Coombs-reactive, polyclonal, humanB-04250861815541On the marketAnti-Jka Coombs-reactive, polyclonal, humanB-04250861803418On the marketAnti-Jka for card method, Coombs-reactive, polyclonal, humanB-04250861815558On the marketAnti-Jka for card method, monoclonal, human IgM clone: MS-15B-04250861815565On the marketNo certificate specifically references this device's Basic UDI-DI.