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EUDAMED last updated this device on Jul 11, 2023
B-05999565780227Holotype HLA 24/7 - Configuration A3 & CE v2 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by Omixon Biocomputing Ltd.. Placed on the EU market in Hungary. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
HU-MF-000003018CE 694131(01)05999565780227
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Product Use Limitations For the best performance, please use the Holotype HLA 24/7 kit workflow and Omixon HLA Twin software for HLA typing by NGS with the materials, reagents, and equipment recommended in “Equipment, reagents, and supplies” section. Use of materials other than specified in section “Equipment, reagents, and supplies” section must be verified and validated by the user. Do not reconstitute or dilute the reagents in volumes other than described in this IFU. Do not use less volume of the reagents other than specified in this IFU. These activities can lead to performance errors. Omixon cannot provide support for any problems resulting from not following the protocol steps described in this IFU. Do not use the product in case of detectable damage to the components (broken vials, plate, loose caps etc.). Known Product Limitations Please refer to the Known Product Limitations (KPL)document for known ambiguities and known software limitation of the Holotype HLA product. The KPL is bundled with the IFU and also Omixon Holotype HLA 24/7 – Configuration A1/A2/A3/A4 & CE v2 Instructions for Use. For in vitro diagnostic use. Protocol version: v3.0.2; Document version: v5 Copyright© 2023, Omixon Biocomputing Ltd. Confidential & Proprietary Page 8 │ 57 available on the Omixon website under MyHolotype > Support and Services > HLA Twin Instructions for Use, or you can request it from support@omixon.com.
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 Hungary; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| HungaryPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Slovenia | — | 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.
05999565780227Basic 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-05999565780227H58UDI 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.
W01030499TISSUE TYPING REAGENTS - OTHERPrimary 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-05999565780340On the marketHolotype HLA 24/7 - Configuration A1 & CE v2B-05999565780265On the marketHolotype HLA 24/7 - Configuration A2 & CE v2B-05999565780241On the marketHolotype HLA 24/7 - Configuration A4 & CE v2B-05999565780203On the marketHolotype HLA 96/11 - Configuration A & CE v2B-05999565780173On the marketHolotype HLA 96/11 - Configuration B & CE v2B-05999565780142On 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.