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US-MF-000020921Dilution Solution is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Immucor GTI Diagnostics, Inc. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 13, 2022
88823411W01030403C004JKHPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)10888234500827
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
Some reagents contain 0.1% sodium azide as a preservative, which may react with lead and copper plumbing to form explosive metal azides. Use large amounts of water when discarding materials down a sink.
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 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Sep 30, 2020 | Still on market |
| Austria | Sep 30, 2020 | Still on market |
| Belgium | Sep 30, 2020 | Still on market |
| Bulgaria | Sep 30, 2020 | Still on market |
| Cyprus | Sep 30, 2020 | Still on market |
| Czechia | Sep 30, 2020 | Still on market |
| Denmark | Sep 30, 2020 | Still on market |
| Estonia | Sep 30, 2020 | Still on market |
| EL | Sep 30, 2020 | Still on market |
| Spain | Sep 30, 2020 | Still on market |
| Finland | Sep 30, 2020 | Still on market |
| France | Sep 30, 2020 | Still on market |
| Croatia | Sep 30, 2020 | Still on market |
| Hungary | Sep 30, 2020 | Still on market |
| Ireland | Sep 30, 2020 | Still on market |
| Iceland | Sep 30, 2020 | Still on market |
| Italy | Sep 30, 2020 | Still on market |
| Liechtenstein | Sep 30, 2020 | Still on market |
| Lithuania | Sep 30, 2020 | Still on market |
| Luxembourg | Sep 30, 2020 | Still on market |
| Latvia | Sep 30, 2020 | Still on market |
| Malta | Sep 30, 2020 | Still on market |
| Netherlands | Sep 30, 2020 | Still on market |
| Norway | Sep 30, 2020 | Still on market |
| Poland | Sep 30, 2020 | Still on market |
| Portugal | Sep 30, 2020 | Still on market |
| Romania | Sep 30, 2020 | Still on market |
| Sweden | Sep 30, 2020 | Still on market |
| Slovenia | Sep 30, 2020 | Still on market |
| Slovakia | Sep 30, 2020 | Still on market |
| Türkiye | Sep 30, 2020 | Still on market |
| XI | Sep 30, 2020 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
10888234500827Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
88823411W01030403C004JKH628515UDIUDI 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.
W01030403HLA ANTIGEN TYPINGNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HX 1804149-1SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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