- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Dec 21, 2023
++G286HSeqDPBMGH-Seq-DPB Sequenzierungskit für 48 Typisierungen is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
+G2860150-015DE-MF-000018980+G2860150-
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
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 Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01030403HLA ANTIGEN TYPINGW0106010401HLA-TYPINGPrimary 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.++G286HSeqABCKROn the marketH-Seq-DQB Sequenzierungskit für 48 Typisierungen++G286HSeqDQBMKOn the marketH-Seq-DR Sequenzierungskit für 48Typisierungen++G286HSeqDRHHOn the marketH-Seq-LR-NGS Sequenzierungskit für 48 Typisierungen++G286LongRangeNGS7KOn the marketNo certificate specifically references this device's Basic UDI-DI.